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Evidence-based guidelines for chlorhexidine gluconate in preoperative skin preparation to reduce surgical site infection in patients undergoing general surgery Lai, Shuk-tin; 黎淑鈿 Lai, S. [黎淑鈿]. (2013). Evidence-based guidelines for chlorhexidine gluconate in preoperative skin preparation to reduce surgical site infection in patients undergoing general surgery. (Thesis). University of Hong Kong, Pokfulam, Hong Kong SAR. Retrieved from http://dx.doi.org/10.5353/th_b5088355 2013
http://hdl.handle.net/10722/193047
Creative Commons: Attribution 3.0 Hong Kong License
Abstract of thesis entitled “Evidence-based Guidelines for Chlorhexidine Gluconate in Preoperative Skin Preparation to Reduce Surgical Site Infection in Patients Undergoing General Surgery” Submitted by Lai, Shuk Tin for the degree of Master of Nursing at The University of Hong Kong in August 2013
Surgical site infection not only brings morbidity and mortality to patients, but it also bring substantial financial burden to the hospital and the healthcare system. To minimize the clinical consequences of surgical site infection, it is crucial that all appropriate measures for reduction of surgical site infection should be implemented. Since patient’s skin is a potential source of pathogens, normal skin flora isa common cause of surgical site infections. Preoperative skin disinfection of the surgical site with an antiseptic agent is an effective method to remove the soil and transient organisms from the skin.Currently, there are different skin antiseptics available and the most commonly used agents are povidone iodine and chlorhexidine gluconate. Although povidone iodine has a long-standing recommendation and it is widely used in various surgical procedures, it has several limitations.On the other hand, there isan increasing interest of the use i
of chlorhexidine in indwelling catheter placement and care, surgical hand scrubbing, as well as wound dressing.
In view of this, there is a potential of replacing povidone iodine by chlorhexidine as preoperative skin antiseptic agent. As there is no existing guideline supportingthis innovative movement, this dissertation aimed to review the currently available evidence on preoperative skin preparation and to develop an evidence-based guideline of using chlorhexidine in preoperative skin preparation for reducing surgical site infection in patients undergoing general surgery.
Five randomized controlled studies were identified from MEDLINE, CINAHL and PUBMED and evaluated by a critical appraisal tool, the Scottish Intercollegiate Guidelines Network. All studies reported that preoperative skin preparation with chlorhexidine is more effective than the use of povidone iodine in reducing surgical site infection. Anevidence-based guidelineis developed according to the guideline development process from the Scottish Intercollegiate Guideline Network. Patient characteristics, local clinical setting, organizational infrastructure and staff competency is congruent with the proposed innovation. The new protocol not only can minimize the risk of postoperative surgical site infection but also save costs. The cost-benefit analysis showed that the new protocol can help to save $675,552 to $1,097,772 (HK dollars) in six-month period after implementation.
To facilitate a more comprehensive plan in actual implementation of the proposed guideline, stakeholders at administrative, managerial, and operational levels would be invited to take part in
ii
the 12-week pilot test.Surgical site infection, staff satisfaction and compliance, as well as cost and benefit ratio of the guideline would be measured in the evaluation plan. The refined guidelines would then be implemented for one year. The effectiveness of the guidelinewould be determined by reduction in postoperative surgical site infection, increase in staff knowledge and satisfaction, and the overall expenditure.
iii
Evidence-based Guidelines for Chlorhexidine Gluconate in Preoperative Skin Preparation to Reduce Surgical Site Infection in Patients Undergoing General Surgery” by Lai Shuk Tin R.N., B.N.
A thesis submitted in partial fulfillment of the requirements for the Degree of Master of Nursing at the University of Hong Kong. August, 2013
iv
DECLARATION I declare that this dissertation represents my own work, and that it has not beenpreviously included in a thesis, dissertation or report submitted to this University or to any other institution for a degree, diploma or other qualifications.
___________________________________ Lai, Shuk Tin September 2013
i
ACHKNOWLEDGEMENTS I would like to take this opportunity to express my gratitude to mysupervisors, Dr. Daniel Yee-Tak Fong and Dr.Dennis Chow for their enlightenment, guidance and patience throughout my long and hard journey for this dissertation and the whole master studies. I am also grateful to my family and classmates who showed me their support and encouragement during my study in the Master of Nursing degree course.
ii
CONTENTS Declaration ……….…………………………………………………………………………..
i
Acknowledgements ……………………………………………………………………………
ii
Table of Contents ……………………………………………………………………………..
iii
List of Illustration…………………………………………….……………………………….
v
CHAPTER 1: INTRODUCTION 1.1
Background ………………………………………………………………... 1
1.2
Affirming Needs ………………………………………………………...…
2
1.3
Objectives & Significance ………………...……………………………….
5
CHAPTER 2: CRITCAL APPRAISAL 2.1
Search & Appraisal Strategies ………………………………......................
7
2.1.1 Identification of studies 2.1.2 Selection Criteria 2.1.3 Data Extraction 2.1.4Appraisal Strategies 2.2
Results…………….……………………………………..………………… 2.2.1 Search Results 2.2.2 Study Characteristics
iii
9
2.2.3 Methodology Quality Assessment 2.3
Summary & Synthesis ……………………………………………………..
14
2.3.1 Summary 2.3.2 Synthesis
CHAPTER 3: TRNSLATION AND APPLICATION 3.1
Implementation Period ……………………..……………………………...
19
3.1.1 Transferability of the findings 3.1.2 Feasibility 3.1.3 Cost-benefit ratio of the innovation 3.2
Evidence-based Protocol………………........………..………………….…
26
CHAPTER 4: IMPLEMENTATION PLAN 4.1 Communication Plan...……………………..……..………………………..
27
4.1.1 Identification of Stakeholders 4.1.2 Communication Process and Strategies 4.2 Pilot Study Plan……………………………………………………………. 4.2.1 Objectives 4.2.2 Target Setting and Population 4.2.3 Time Frame 4.2.4 Outcomes Measure iv
29
4.2.5 Data Collection 4.2.6 Analysis and Evaluation of the Pilot Test Results 4.3 Evaluation Plan…………………………………………………………….
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4.3.1 Outcomes 4.3.2 Nature of Subjects 4.3.3 Sample Size 4.3.4 Timing and Frequency of Outcome Measurement 4.3.5 Analysis of Data 4.3.6 Criteria for Determining Guideline Effectiveness
APPENDICES I
Evidence table …………………………………....................................................
37
II
SIGNS Methodology Checklist……………………………………………….......
38
III
SIGNS Level of Evidence……………………………………………….……......
40
IV
Quality assessment for individual study ………………………………….…...….
41
V
Estimated set up cost of the new guideline……………........................................
51
VI
Estimated saving from the new guideline.………………………………….……..
52
VII
The evidence-based guideline……………………………………………….….....
53
VIII
Timeline and Communication Plan ………………..………………………….….
59
IX
Data collection sheet.………………………………………………………..….....
60
X
Staff survey …………………………………………………………………….…
61
v
REFERENCES ……………………………………………………………..……………
vi
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CHAPTER 1 INTRODUCTION
1.1 Background The Centers for Disease Control and Prevention reported that surgical site infections made up 14% to 16% of all infections and it is the third most frequently reported hospitalacquired infection worldwide (Centers for Disease Control and Prevention, 2009). Surgical site infection delays the recovery and may inflict serious adverseimpact on surgical patients. Patients with postoperative surgical site infection not only suffer from increased pain and physical discomfort, they are their family members may also have a decreased quality of life (Biscione, 2009). Moreover, there are other short-term and long-term negative consequences. For patients with infective complications, their survival rate after an operation is significantly lower than in patients without infection (Nespoli et al, 2006). In addition, it has been reported that patients with surgical site infection are 1.9 times more likely to have an incisional hernia (Murray et al, 2011). Apart from the clinical adverse consequences, surgical site infection increases the financial burden on both patients and hospitals. Graf et al. (2011) reported that surgical site infection almost tripled the individual costs on medical treatment. The delayed recovery one one hand hinders the patient from resuming work and thus reduces her productivity. One the other hand, the additional stay in hospital increases her expenditure onmedical and surgical treatment and also pain management. Other additional expense include the extra money needed from her family caregiver on visiting and subsequent follow-up visit to doctors. Prolonged hospital stay
1
also increases patients’ risk of other adverse health outcomes (e.g. pressure ulcers, medication reactions, or use of urinary or other indwelling catheters).All these adversities could result in subsequent hospital-acquired infections (Graf et al., 2011). de Lissovoy et al. (2009) revealed that that, depending on the types of surgery, surgical site infection raised hospital stay by 9.7 days and the cost treatment by $20,842 (US dollars). Additionally, in both public and private hospitals, surgical site infection increases hospital costs significantly (Dimick et al, 2004).
1.2 Affirming the Needs Of an operation theater in a private hospital of Hong Kong which carries out different types of operations, the overall surgical site infection rate ranges from 3.1% to 7% in 2011 (Infection control team, 2011). This rate is comparable to other hospitals in Hong Kong. However, since surgical site infection is an unwanted postoperative outcome which brings serious adverse consequences and huge financial burden to both surgical patients and hospitals, further effort should be made to eradicate this problematic issue.
To minimize the clinical consequences of surgical site infection, it is crucial that all appropriate measures are implemented (Biscione, 2009). In the local setting, preventive measures such as environmental control, instruments sterilization, sterile techniques, and administration of perioperative antibiotics have been implemented to keep surgical wound from being contaminated by infectious organisms. However, despite all the effort, the risk of postoperative infection has not been eradicated. Since patient’s skin is a potential source of pathogens, Normal skin flora including staphylococcus aureus and coagulase-negative staphylococci, are common
2
causes of surgical site infections (Bhavan & Warren, 2009). Therefore, preoperative skin preparation has an important role in preventing surgical site infection.
Preoperative skin disinfection of the surgical site with an antiseptic agent is an effective method to remove the soil and transient organisms from the skin (AORN Standard, 2006). Antiseptic skin preparation products are formulated to quickly kill a wide spectrum of pathogens and to provide a persistent and high level of antimicrobial action (Digison, 2007). Currently, there are different skin antiseptics available and the most commonly used agents are povidone iodine and chlorhexidine (Lepor & Madyoon, 2009). As the antiseptic agents has various capabilities on removing and destroying pathogens on patient skins, adequate selection is critical for the prevention of surgical site infection.
In local departments, povidone iodine is routinely used for skin preparation for most of the open general surgeries. Povidone iodine performs its antiseptic action by releasing free iodine and that binds to microbes, resulting in destruction of their cellular structures and enzymes (Chernesky & Mahoney, 1990). Despite its longstanding recommendation and popularity, it has several limitations. First, it causes redness on patient’s skin. In addition, as it only has a moderate action, the drying time for an optimal antiseptic function, on average, is 3 minutes (Zinn et al, 2010). However, operation is always under a quick pace, patient’s skin is often dried with sterile towel and incised before an optimal disinfection. This greatly hinders the function of povidone iodine on antiseptic skin preparation. Moreover, the brown color of povidone iodine stains patient’s skin even after several hours of the operation. Extra effort is needed for removing the stain postoperatively and this increases risk of skin irritation or local pain. Recently, a surgeon
3
reported that povidone iodine stain was found at the back of his patient 4-to-5 days after the breast surgery. This might be due to an incomplete removal of the povidone iodine solution postoperatively. Since surgical patient was prohibited from bathing, the delay can make the removal even harder.
There has been an increasing interest in the use of chlorhexidine worldwide. It kills microbes by destructing their cell membranes and thus causing leakage of the cellular contents (Chernesky & Mahoney, 1990). In recent year, extensive studies have compared chlorhexidine and povidone iodine on their antiseptic power. The use of chlorhexidine has demonstrated lower bacterial count and better infection prevention in indwelling catheter placement and care (Munoz-Price et al, 2012), surgical hand scrubbing (Lai et al, 2012), and wound dressing (Eardley, Watts, & Clasper, 2012). Furthermore, immediate skin incision can be done after using chlorhexidine in skin preparation as it does not require a waiting time for action (Zinn et al, 2010). It is much more time saving and, even in emergency surgical procedures, antiseptic power can be ensured. In view of this, there is a potential of replacing povidone iodine by chlorhexidine as preoperative skin antiseptic agent.
Surgical site infection not only brings morbidity and mortality to patients but also substantial financial burden to the hospital and the healthcare system. Perioperative nurse plays an important role in minimizing the incidence of surgical site infection by rigorous adherence to aseptic techniques and also respond quickly to the most updated evidence-based practice. This paper reviewed the available evidence on preoperative skin preparation and aims to develop
4
evidence-based guidelines of using chlorhexidine in preoperative skin preparation for reducing surgical site infection in patients undergoing general surgery.
1.3 Objectives & Significance In response to the need of an evidence-based guideline using chlorhexidine in preoperative skin preparation, the following objectives would be achieved in this dissertation.
1. To systematically evaluate the current evidence on the use of povidone iodine and chlorhexidine in preoperative skin preparation. 2. To develop an evidence-based practical guideline on using chlorhexidine in preoperative skin preparation for general surgery. 3. To assess the transferability and feasibility of implementing the evidence-based practical guideline in a local hospital. 4. To develop an implementation and evaluation plan for the use of the evidence-based practical guideline in a local hospital.
By implementing an effective evidence-based practical guideline, the incidence of surgical site infection can be greatly reduced. Since adverse postoperative outcomes are minimized, surgical patients and their caregivers can resume their normal lives as soon as possible. This is beneficial in both physical and psychological aspects. For healthcare professionals, time could be saved on preoperative skin disinfection and postoperative cleaning of patient skin. For
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economical concern, additional medical cost due to infection can be save and the hospital can use the recourses for other constructive development.
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CHAPTER 2 CRITICAL APPRAISAL
2.1 Search Strategies 2.1.1 Identification of studies For identification of studies, electronic databases including Medline, PubMed and CINHAL were systematically searched in July 2012 with keywords “chlorhexidine”, “povidone iodine” and “surgical wound infection”. A constraint was set for studies with human species, adults aged 18 or above, and randomized control trial. Manuscripts published in any languages were included in the search. After the search, titles and abstracts of the retrieved manuscripts were carefully screened. For those satisfied the inclusion criteria, their full texts were reviewed for eligibility. Manual search of the reference lists of the eligible studies was also performed for identifying any additional relevant studies.
2.1.2 Selection Criteria Studies were included if they meet the following inclusion criteria: 1. Participants of the study were adult surgical patients who were subjected to general surgery; 2. Chlorhexidine and povidone iodine were compared; 3. Surgical site infection was considered as an outcome measure; and 4. Study design was randomized controlled trial (RCT).
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Studies were excluded if they meet the following exclusion criteria: 1. Study concerning only bacterial load or skin flora count; 2. Study used chlorhexidine and povidone iodine for surgical hand scrubbing, wound dressing, preoperative shower, intraoperative peritoneal lavage, indwelling catheter care and mouth care; or3. Study considering patients undergoing laparoscopic surgery only.
2.1.3 Data Extraction Information of the eligible studies were extracted for further analysis. These information include study design, characteristics of participants, intervention and control, application method of the solutions, length of follow up, outcome measures such as surgical site infection rate, bacterial colonization and colony-forming units, and the effect size. Table II provides a summary of the extracted data from the reviewed studies.
2.1.4 Appraisal Strategies The Scottish Intercollegiate Guidelines Network (SIGNS, 2012), a critical appraisal tool, was used for the evaluation. The SIGN methodology checklist is a reliable tool which aids a systematic review of current evidence and development of an evidence-based clinical guideline. The individualized checklist for randomized control trials provided a comprehensive assessment on the research question, randomization method, concealment method, comparability of groups, internal validity, methodology and the generalizability of the study results. After assessing the methodological quality, level of evidence of the study was rated by a coding system, “++”, “+”
8
or “-“. The SIGNS methodology checklist for quality appraisal and its guideline for Level of Evidence can be found in Appendix I and II respectively. All included studies were systematically reviewed in accordance to the SIGNS checklist and details can be found in Appendix IV.
2.2 Results 2.2.1 Search Results The search was conducted in August, 2012. Based on the search from the three electronic databases, 172 manuscripts were identified and, after initial screening, 32 were retained. A secondary screening focusing on the titles and the abstracts further reduced the result to 10 manuscripts. Reasons of the exclusion is: The intervention, participates or outcome measures of the study reported in these manuscripts do not match the inclusion criteria. Among the 10 manuscripts, some reported on the same study and one reported a cohort study and were thus excluded. Hence, 4 eligible studies were yielded from the database search. Furthermore, manual search of the systematic review and the eligible studies was done and one additional study was identified. Therefore, there were in total 5 studies included. The searching plan is presented in the following flow chart diagram (Figure I). To give a clearer picture of the searching plan, the search results from each electronic databases and table of search results are presented in table I.
9
Figure I. Flow chart of searching strategy Medline
PudMed
CINHAL
Key words search: “chlohexidine” AND “povidone iodine” AND “surgical wound infection”
61
75
36
Limit to: “human” and “adult”
19
23
6
Limit to: “RCT”
13
14
6
Exclude negligible studies
Repeated study: 0 Excluded: 10
Repeated study: 1 Excluded: 8
4
4 Merge results Exclude repeated studies
4
Eligible studies: 1
Manual search of reference list
Total included studies
5 RCTs
10
Repeated study: 0 Excluded: 5
1
Table I. Table of search results
Manual search
CINAHL
PubMed
Medline
Febrile morbidity
Skin culture
Outcome not matched Bacterial load
Pacemaker care
Mouth care
Darouiche et al., 2010 Paocharoen et al, 2009 Berry et al., 1982 Bibbo et al., 2005 Brooks et al., 2001 Cheng et al., 2009 Veiga et al., 2008 Kalantar-Hormozi et al., 2005 Stahl et al., 2007 Sistla et al., 2010 Sowapat et al., 2006 Vallance, & Waldron, 1985 Darouiche et al., 2010 Paocharoen et al, 2009 Parienti et al., 2009 Berry et al., 1982 Bibbi et al., 2005 Brooks, 2001 Cheng et al., 2009 Veiga et al., 2008 Kalantar-Hormozi et al., 2005 Saltzman et al., 2009 Stahl et al., 2007 Sistla et al., 2010 Sowapat et al., 2006 Vallance, & Waldron, 1985 Alfzal et al., 2009 Darouiche et al., 2010 Bibbi et al., 2005 Bonatti et al., 2009 Ramsdale et al., 1984 Saltzman et al., 2009 Brown et al., 1984
Study type not matched
Peritoneal lavage Indwelling catheter care
1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 1 2 3 4 5 6 1
Include
Pre-op shower
Citations of final search result
Population not matched
Wound dressing
No
Intervention not matched Other antiseptic agents Surgical hand scrub
Electronic database
Exclude
● ● ● ● ● ● ● ● ●
● ● ●
● ●
●
● ● ● ● ●
●
● ● ● ●
●
●
● ● ● ●
● ●
● ● ● ● ● ●
11
2.2.2 Study Characteristics The eligible RCTs were conducted between year 1982 and 2010 in the United Kingdom (Berry et al., 1982), India (Paocharoen et al, 2009), Thailand (Sistla et al., 2010) and the United States (Darouiche et al., 2010; Brown et al., 1984).
All studies compared the efficacy of chlorhexidine and povidone iodine on postoperative surgical site infection. Success of obtaining ethical approval is reported in three studies. Study characteristics are summarized in the table of evidence (Table II). Study participants were adult surgical patients underwent general surgeries. Only one study focused on one type of surgery, herniorrhaphy (Sistla et al., 2010). All studies used chlorhexdine as the test and povidone iodine as the control treatment. The application methods of the two solutions were clearly stated. Four reviewed studies reported the length of the follow-up period, ranging from 3-to-4 days to 1 month. One study however did not mention about the length of the follow-up (Brown et al., 1984). In addition to the outcome of surgical site infection rate, some studies further classified infection into different types (e.g. superficial incisional, deep incisional, organ space and sepsis). Other outcomes measured in these studies include postoperative length of stay, bacterial counts and allergy reaction.
2.2.3 Methodology Quality Assessment Of the 5 RCTs, the methodology used in one study was in high quality (Darouiche et al., 2010); three were moderate (Berry et al., 1982; Brown et al, 1984; Sistla et al., 2010); and one was poor (Paocharoen et al., 2009). Assessments of the quality of each study are listed in Appendix III. 12
The focused questions were clearly stated in all studies. Regarding randomization, the utilized methods included computer-generated stratification (Darouiche et al., 2010), random number table (Berry et al, 1982), and stratified randomization (Brown et al., 1984). Two studies on the other hand did not report details of the randomization process (Paocharoen et al., 2009; Sistla et al 2010). For concealment method, only one study did not report it (Paocharoen et al., 2009). Three studies used sealed envelopes method (Berry et al, 1982; Brown et al., 1984; Sistla et al 2010) and one used centralized allocation (Darouiche et al., 2010) to keep the researchers and participants unaware of the treatment group allocation. For blinding method, two studies stated that participants and investigators were unaware of treatment group assignment throughout the study (Darouiche et al., 2010; Sistla et al 2010).
The sample size of the studies were all over 400 and sample size calculation was only reported in the study of Darouiche et al. (2010). For baseline measures (i.e. demographic factors, preoperative conditions, coexisting health problems, duration and type of surgery and risk factors for infection), all studies reported no significant differences between patients in the intervention and control groups. Most of the studies standardized the preoperative use of antibiotics in order to control the difference between the two groups. However, in the study conducted by Brown et al. (1984), operating surgeons were allowed to decide their choice of systemic antibiotic and this might be a potential confounding variable that jeopardizes the validity of their study results.
All the primary and secondary outcomes were clearly stated and they were measured in a standardized method. All studies reported that they use the guideline of wound assessment developed by Center of Disease and Control for assessing surgical wounds postoperatively. In
13
three of the studies (Berry et al., 1982; Brown et al, 1984; Darouiche et al., 2010;), the surgical wounds of both study groups were assessed and documented by the same group of investigators and this minimized the bias due to the difference of individual perception. Assessment of surgical wounds in Paocharoen et al.’s study (2009) was relied on surgeons’ own judgment and this could reduce the inter-rater reliability. Questionnaires were used to record surgical site infection in the study by Sistla et al., (2010). The method of self-repot for data collection was susceptible to the response bias and misunderstanding.
Concerning the dropout rate, the study of Paocharoen et al. (2009) claimed that there was no dropout whereas, in the study of Darouiche et al. (2010), two dropouts in each study group was reported. Sisla et al (2010) reported the dropout rate in their study was less than 5 %. The amount of missing value across these three studies was small and thus it is unlikely to affect their study outcomes. The other two studies did not mention their dropout rates (Berry et al., 1982; Brown et al, 1984). The intention-to-treat principle was only adopted in Darouiche et al. (2010) but not in other studies. In addition, Darouiche et al.’s study (2010) was the only one carried out in multiple sites so its generalizability was comparatively greater than the other studies.
2.3 Summary & Synthesis 2.3.1 Summary All five studies compared chlorhexidine with povidone iodine and evaluated their efficacy on the prevention of surgical site infection. In these studies, chlorhexidine in concentration ranged from 0.5% to 4% in 70% alcohol and povidone iodine in concentration of 10% were used. 14
The application method varied across studies. Two studies used simply painting (Berry et al., 1982; Sistla et al., 2010) and other studies used painting together with scrubbing (Darouiche et al., 2010; Brown et al, 1984; Paocharoen et al., 2009). Only two studies mentioned about the scrubbing and painting time, which ranged from 5 minutes (Paocharoen et al., 2009) to 6 minutes (Brown et al., 1984). Moreover, four studies used the liquid form of chlorhexdine whereas one used the spray form (Brown et al, 1984).
All studies reported that preoperative skin preparation with chlorhexidine is more effective in reducing surgical site infection than using povidone iodine (Darouiche et al., 2010; Paocharoen et al, 2009; Berry et al., 1982; Brown et al., 1984; Prabhu et al., 2010). The additional reduction was significant except in studies of Sistla et al. (2010) and Paocharoen et al. (2009). When the two solutions were compared on the level of infections, studies showed that chlorhexidine had a significant greater action on superficial incisional wound (P=0.008), deep incisional wound (P=0.04) (Darouiche et al., 2010), and hematoma (P=0.044) (Brown et al., 1984). A lesser difference between the two solutions was observed on organ space (P=0.0919), sepsis (P=0.199) (Darouiche et al., 2010), and wound separation (P=0.120) (Brown et al., 1984). Two studies also compared the solutions by bacterial counts. Postoperative bacterial count were significantly lower with the use of chlorhexidine (P 18
1+
Hernia I group 157 43 7 193 159 41
Age ≤ 60 > 60 Female Male OT55min
1-
General surgery Age/yr Female Male OT/hrs
I group 50.5 (18-78) 91 159 1.45
Intervention
Comparison
Application Method
2% CH in 70% IA C group (n=391) 52.9 +14.2 122 55.9 3.0±1.5 0.5% CH in sprit (n=453)
10% PVI (n=422)
Scrub then paint
10% PVI in alcohol (n=413)
Paint
0.5% CH in 70% IA spray (n=378)
10% PVI (n=359)
2.5% CH in 70% IA C group (n=200) 149 51 2 198 161 39
10% PVI (n=200)
6 mins PVI soap scrub then dried, then PVI paint or CHG spray Paint then allow to dry
4% CH in 70% IA C group (n=250) 56.2 (20-79) 122 138 1.43
PVI (n=250)
5 mins scrub 5 mins paint
Length of follow up
Outcome measures
Effect size (Intervention - Control)
Primary Primary 1) SSI (case) 1) -0.066 (P=0.004) Secondary Secondary 2) Grade of infection (case) 2) a) -0.044 (P=0.008) a) Superficial b) -0.120 (P=0.04) b) Deep c) -0.0014 (P=0.919) c) Organ/ space d) -0.016 (p=0.199) d) Sepsis 3-4 days Primary Primary 1) SSI (case) 1) -0.005 (P=0.011) Secondary Secondary 2) Significant bacterial growth 2) -0.01 (P=0.22) (case) Primary Not Primary 1) SSI (case) 1) -0.05 (P=0.01) mention Secondary Secondary 2) Grade of infection (case) 2) a) -0.10 (P=0.120) a) Separation b) -0.01 (P=0.044) b) Hematoma/ Seroma 30 days Primary Primary 1) Reduction in BC (×102 CFU) a) Overall 1) a) -22.86 (P=0.787) b) -45.4 (P=0.507) b) Infected c) -11.35 (P=0.402) c) Non-infected 2) -0.025 (P=0.364) 2) SSI (case) Secondary Secondary 3) BC (×102 CFU) 3) a) -6.32 (P=0.085) a) Before b) -1.41 (P=0.053) b) After 4) -53.88 (P=0.001) 4) Postop BC: preop hospital stay to ≤48 to >48 hrs (×102 CFU) 5) Grade of SSI (case) 5) a) -0.01 (P=0.558) b) -0.01 (P=0.630) a) Grade 1 c) -0.005 (P=0.562) b) Grade 2 c) Grade 3 1 mth Primary Primary 1) Postop BC >103CFU/ml 1) -0.168 (P103CFU/ml (case) a) S.epidermidis b) -0.016 (P=0.201) b) S.aureus c) -0.044 (P=0.024) c) Streptococcus sp. d)-0.004 (P=0.316) d) Enterococcus sp. 4) 2 cases in PVI group 4) Allergy reaction (case) 30 days
RCT= Randomized control trail, I= Intervention, C= Control, OT = Operation time, CH=Chlorhexdine, IA = Isopropyl alcohol, PVI = Povidone–iodine, BC= Bacterial colonization, CFU=Colony-forming units (CFU)/ml SSI= Surgical site infection, P=P value
37
Appendix II.SIGNS SIGNS Methodology Checklist MethodologyChecklist ethodologyChecklist 2: Controlled Trials SIGN Study identification (Include Include author, title, year of publication, journal title, pages)
Guideline topic:
Key Question No:
Before completing this checklist, consider: 1. Is the paper a randomized controlled trial or a controlled clinical trial?? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+ 2. Is the paper relevant elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist. Reason for rejection: Reason for rejection: 1. Paper not relevant to key question
□
2. Other reason
(please specify): Checklist completed by:
SECTION 1: INTERNAL VALIDITY In a well conducted RCT study…
In this study this criterion is:
1.1
Well covered
Not addressed
Adequately addressed
Not reported
Poorly addressed
Not applicable
Well covered
Not addressed
Adequately addressed
Not reported
Poorly addressed
Not applicable
Well covered
Not addressed
Adequately addressed
Not reported
Poorly addressed
Not applicable
Well covered
Not addressed
Adequately addressed
Not reported
Poorly addressed
Not applicable
Well covered
Not addressed
Adequately addressed
Not reported
Poorly addressed
Not applicable
1.2
1.3
1.4
1.5
The study addresses an appropriate and clearly focused question.
The assignment of subjects to treatment groups is randomised
An adequate concealment method is used
Subjects and investigators are kept ‘blind’ about treatment allocation
The treatment and control groups are similar at the start of the trial
38
□
1.6
1.7
The only difference between groups is the treatment under investigation
All relevant outcomes are measured in a standard, valid and reliable way
Well covered
Not addressed
Adequately addressed
Not reported
Poorly addressed
Not applicable
Well covered
Not addressed
Adequately addressed
Not reported
Poorly addressed
Not applicable
1.8
What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
1.9
All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered
Not addressed
Adequately addressed
Not reported
Poorly addressed
Not applicable
Where the study is carried out at more than one site, results are comparable for all sites
Well covered
Not addressed
Adequately addressed
Not reported
Poorly addressed
Not applicable
1.1 0
SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1
How well was the study done to minimise bias? Code ++, +, or
2.2
Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
2.3
Are the results of this study directly applicable to the patient group targeted by this guideline?
2.4
Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question.
39
Appendix III.SIGNS Level of Evidence Level of Evidence (Scottish Intercollegiate Guidelines Network, 2011) Level of evidence
Descriptions
1++
High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+
Well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias
1-
Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++
High quality systematic reviews of case control or cohort studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal
2+
Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal
2-
Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal
3
Non-analytic studies, e.g. case report, case series
4
Expert opinion
40
Appendix IV.Quality Quality assessment for individual study MethodologyChecklist ethodologyChecklist 2: Controlled Trials SIGN Study identification (Include Include author, title, year of publication, journal title, pages pages)
AlSharif, A., Awad, S.S., Berger, D.H., Carrick, M.M., Crosby, C.T., Darouiche, R.O., Itani, K.M.F., Miller, H.J., Mosier, M.C., Otterson, M.F., Wall, M.J., Webb, A.L. Chlorhexidine Chlorhexidine–Alcohol Alcohol versus Povidone-Iodine for Surgical-Site Site Antisepsis N Engl J Med 2010;362:18 2010;362:18-26 Guideline topic:
Key Question No:
Before completing this checklist, consider: 3. Is the paper a randomized controlled trial or a controlled clinical trial?? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and a the study cannot be rated higher than 1+ 4. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist. Reason for rejection: Reason forr rejection: 1. Paper not relevant to key question
□
2. Other reason
□ (please specify): Checklist completed by:
SECTION 1: INTERNAL VALIDITY In a well conducted RCT study…
In this study this criterion is:
1.1
The study addresses an appropriate and clearly focused question.
1.2
The assignment of subjects to treatment groups is randomised
Well covered. The aim of the study was clearly stated in introduction. Well covered. Randomization was stratified by hospital with the use of computer-generated generated randomization
1.3
An adequate concealment method is used
Adequately addressed. Centralized allocation by hospital was used.
1.4
Subjects and investigators are kept ‘blind’ about treatment allocation
1.5
The treatment and control groups are similar at the start of the trial
Well covered. Both the patients and the site investigators who diagnosed surgical site infection remained unaware of the group assignment. Well covered. Patients in two study groups were similar with respect to demography characteristics, coexisting illness, risk factors for infection, antimicrobial exposure, duration, type of surgery.
41
Well covered. The only difference between the groups was the preoperative skin antiseptic preparation which is the intervention under study. Adequately addressed. The diagnosed of surgical site infection was on the basis of criteria developed by CDC. The wounds were assessed by same investigation Intervention group: 2 Control group: 2
1.6
The only difference between groups is the treatment under investigation
1.7
All relevant outcomes are measured in a standard, valid and reliable way
1.8
What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
1.9
All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Well covered. Intention to treat was used in the study.
1.1 0
Where the study is carried out at more than one site, results are comparable for all sites
Well covered. Results were comparable.. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed.
SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1
How well was the study done to minimise bias? Code ++, +, or
1++ Adequate blinding, concealment, similar group characteristics, intention-to-treat, multiple sites.
2.2
Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes. This study was conducted in a systematic manner. It was of high methodological quality.
2.3
Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes.
2.4
Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question.
-
The application of chlorhexidine-alcohol reduced the risk of surgical site infection by 41% as compared with povidone-iodine. The effect of povidone-iodine and chlorhexidine-ethanol in the reduction of bacterial counts was not significantly different (59.14 vs. 82%; p = 0.78). The superior clinical protection provided by chlorhexidine-alcohol is probably related to its more rapid action, persistent activity despite exposure to bodily fluids, and residual effect. Although the use of flammable alcohol-based products in the operating room poses the risk, though small, of fire or chemical skin burn, no such adverse events occurred in this study or the other studies. The overall superior protection afforded by chlorhexidine-alcohol was attributed primarily to a reduction in the rates of superficial and deep incisional infections that were caused mostly by grampositive skin flora.
42
MethodologyChecklist ethodologyChecklist 2: Controlled Trials SIGN Study identification (Include Include author, title, year of publication, journal title, pages pages)
Berry, A. R., Goldacre, M.J., McNair, T.J., Thomson, J.W., & Watt, B. (1982). A comparison of the use of povidone-iodine iodine and chlorhexidine in the prophylaxis of postoperative wound infection. Journal of Hospital Infection., 3(1): 55-63. 63. Guideline topic:
Key Question No:
Before completing this checklist, consider: 5. Is the paper a randomized controlled trial or a controlled clinical trial?? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+ 6. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES com complete plete the checklist. Reason for rejection: Reason for rejection: 1. Paper not relevant to key question
□
2. Other reason
□ (please specify): Checklist completed by:
SECTION 1: INTERNAL VALIDITY In a well conducted RCT study…
In this study this criterion is:
1.1
The study addresses an appropriate and clearly focused question.
1.2
The assignment of subjects to treatment groups is randomised
Well covered. The aim of study was clearly stated in the introduction. Adequately addressed. Randomization was done by a table of random numbers.
1.3
An adequate concealment method is used
1.4
Subjects and investigators are kept ‘blind’ about treatment allocation
1.5
The treatment and control groups are similar at the start of the trial
1.6
The only difference between groups is the treatment under investigation
43
Adequately addressed. The authors described that the sequence of randomization was known only to one of the researchers. The result of randomization was recorded on a card and each card was put in a sealed envelope. Not addressed. It was beyond the scope of the study to arrange for observations on patient’s wounds to be made totally blind. Poorly addressed. Age, sex and operation nature were compared without statistical analysis. Insufficient data to prove the similarity between groups. Adequately addressed. The only difference between ween the groups was the preoperative skin antiseptic preparation which is the intervention under study.
Adequately addressed. Wounds were agreed by 2 observers, one member of nursing staff and one member of medical staff. The observation and documentation were taken in a standard format. Swabs were also taken for microbiological test. Not mentioned.
1.7
All relevant outcomes are measured in a standard, valid and reliable way
1.8
What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
1.9
All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Not addressed. Intention-to-treat analysis was not mentioned.
1.1 0
Where the study is carried out at more than one site, results are comparable for all sites
Not applicable. Study was conducted at a single site.
SECTION 2: OVERALL ASSESSMENT OF THE STUDY 1+ The fact that several surgeons participated I the study, several observers were responsible for recording wound observations, and each set of observations was made by two observers, all allowed serious bias to be avoided. Yes.
2.1
How well was the study done to minimise bias? Code ++, +, or
2.2
Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
2.3
Are the results of this study directly applicable to the patient group targeted by this guideline?
2.4
Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question.
-
No.
Wound infection after bililary tract and clean non-abdominal operations was significantly less common among patients prepared with chlohexidine than those prepared with povidone iodine. However, for abdominial operations other than those of the biliart tract, wounf infections were less common among patients prepared with povidone iodine than with chlohexidine.
44
MethodologyChecklist ethodologyChecklist 2: Controlled Trials SIGN Study identification (Include Include author, title, year of publication, journal title, pages pages)
Brown, T. R., Ehrlich, C.E., Eitzen, H.E.,Golichowski, A.M., Madura, J.A., & Stehman, F.B. (1984). A clinical evaluation of chlorhexidine gluconate spray as compared with iodophor scrub for preoperative skin preparation. Surg Gynecol Obstet, 158(4):363 158(4):363-6. Guideline topic:
Key Question No:
Before completing this checklist, consider: 7. Is the paper a randomized controlled trial or a controlled clinical trial?? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+ 8. Is the paper relevant elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist. Reason for rejection: Reason for rejection: 1. Paper not relevant to key question
□
2. Other reason
□ (please specify): Checklist completed by:
SECTION 1: INTERNAL VALIDITY In a well conducted RCT study…
In this study this criterion is:
1.1
The study addresses an appropriate and clearly focused question.
1.2
The assignment of subjects to treatment groups is randomised
Well covered. The aim of study was clearly stated in the introduction. Adequately addressed. Patients were randomized by stratified randomization.
1.3
An adequate concealment method is used
Adequately addressed. Seal envelopes were used.
1.4
Subjects and investigators are kept ‘blind’ about treatment allocation
1.5
The treatment and control groups are similar at the start of the trial
1.6
The only difference between groups is the treatment under investigation
Not addressed. Blinding method was not mentioned in the study, indicating that this aspect of study design was ignored. Well covered. No significant differences between the patients in two groups when analyzed for demographic fators, preoperative conditions, coexisting health problems, hemoglobin concentration, or white wh blood cell counts or prior radiation therapy. Adequately addressed. Use of systemic antibiotic might be different as it was determined by the operating surgeons.
45
Adequately addressed. The infected wounds were inspected by one author to confirm the finding recorded by the surgeon of the patient. Cultures were obtained to the microbiology laboratory for qualitative analysis. 0%
1.7
All relevant outcomes are measured in a standard, valid and reliable way
1.8
What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
1.9
All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Adequately addressed. 100% of the patients had completed inhospital follow-up study
1.10
Where the study is carried out at more than one site, results are comparable for all sites
Adequately addressed. The study results were comparable for the two hospitals.
SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1
How well was the study done to minimise bias? Code ++, +, or
1+ There was a bias with regards to preoperative chemotherapy. The authors did a separate analysis of these patients and revealed that they did not contribute to excess morbidity or affect the overall outcome. So this imbalance did it affect the validity of the result.
2.2
Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes. This study was conducted in a systematic manner. It was of high methodological quality.
2.3
Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes.
2.4
Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question.
-
-
The wound infection rate in the two groups was not statistically different. The spray technique is more convenient and reduces operating room time and anesthesia time from 10 minutes to 30 seconds. This time saving might be crucial to the patient in centein emergency situations such as fetal distress, trauma or ruptured abdominial aortic aneurysm. It is also cost saving and efficient. The total cost savinfs per year is significant. The cost is $0.85 per patient for provodone iodine solution whereas $0.07 for chlorhexidine spray.
46
MethodologyChecklist ethodologyChecklist 2: Controlled Trials SIGN Study identification (Include Include author, title, year of publication, journal title, pages pages)
Prabhu, G., Sadasivan., J., Sistla, S., Sistla, S.C. (2010). Minimizing Wound Contamination in a ‘Clean’Surgery: Comparison of Chlorhexidine Chlorhexidine-Ethanol and Povidone-Iodine. Iodine. Chemotherapy, 56:261– 56:261 267. Guideline topic:
Key Question No:
Before completing this checklist, consider: 9. Is the paper a randomized controlled trial or a controlled clinical trial?? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+ 10. Is the paper relevant elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist. Reason for rejection: Reason for rejection: 1. Paper not relevant to key question
□
2. Other reason
□ (please specify): Checklist completed by:
SECTION 1: INTERNAL VALIDITY In a well conducted RCT study…
In this study this criterion is:
1.1
The study addresses an appropriate and clearly focused question.
1.2
The assignment of subjects to treatment groups is randomised
1.3
An adequate concealment method is used
Well covered. The aim of the study was clearly stated in introduction. Not addressed. The detail of the randomization process not mentioned. Adequately addressed. Sealed envelope method was mentioned.
1.4
Subjects and investigators are kept ‘blind’ about treatment allocation
1.5
The treatment and control groups are similar at the start of the trial
47
Well covered. Concealment to the surgeons was not possible due to the difference in the physical characteristics of the antiseptics. Information regarding the antiseptic used was not available to the investigators or patients during assessment of surgical site infection. Adequately addressed. The patient characteristics cteristics in both the groups were similar. Influence of patient and procedure variables on surgical site infection was under univariate analysis.
Adequately addressed. The only difference between the groups was the preoperative skin antiseptic preparation which is the intervention under study. Adequately addressed. The diagnosed of surgical site infection was on the basis of criteria developed by CDC. The assessment was done by patient selfreport questionnaire Specimens collected to laboratory analysis. Adequately addressed. Not more than 5%.
1.6
The only difference between groups is the treatment under investigation
1.7
All relevant outcomes are measured in a standard, valid and reliable way
1.8
What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
1.9
All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Not addressed. Intention-to-treat analysis was not mentioned.
1.10
Where the study is carried out at more than one site, results are comparable for all sites
Not applicable.
SECTION 2: OVERALL ASSESSMENT OF THE STUDY 1+ Quantitative cultures were performed in only a limited number of patients as a postal questionnaire was used for postdischarge surveillance. Although intention-to treat were not observed, the effect of 5% missing values was relative small.
2.1
How well was the study done to minimise bias? Code ++, +, or
2.2
Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes. Despite of the above potential limitations, the study was conducted in a systematic manner.
2.3
Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes.
2.4
Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question. -
The difference in the incidence of infection between povidone-iodine, 9.5% (19/ 200), and chlorhexidine ethanol, 7.0% (14/200), was not significant (p = 0.364). The effect of povidone-iodine and chlorhexidine-ethanol in the reduction of bacterial counts was not significantly different (59.14 vs. 82%, p = 0.78). Univariate analysis found bilateralism, duration of preoperative stay and duration of surgery (>48hrs) to be significant risk factors for SSI. We observed that the skin bacterial count increased with a longer preoperative stay and the incidence of wound infection was 12.7% in patients with more than 48 h of preoperative hospital stay compared with 5.6% in those with shorter preoperative hospital stay (p = 0.01). In this study, there was significantly more infection in patients in whom the surgical procedure exceeded 55 min (75th percentile time for this study group) (13.7 vs. 6.9%, p = 0.046).
48
- The most common organisms isolated from infected wounds of these patients were Staphylococcus aureus and S. epidermidis.
MethodologyChecklist ethodologyChecklist 2: Controlled Trials SIGN Study identification (Include Include author, title, year of publication, journal title, pages pages)
Apisarnthanarak., A., Mingmalairak, C., Paocharoen , V. Comparison of Surgical Wound Infection after Preoperative Skin Preparation with 4% Chlohexidine and Povidone Iodine: A Prospective Randomized Trial J Med Assoc Thai 2009; 92 (7): 898 898-902 Guideline topic:
Key Question No:
Before completing this checklist, consider: 11. Is the paper a randomized controlled trial or a controlled clinical trial?? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+ 12. Is the paper relevant elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist. Reason for rejection: Reason for rejection: 1. Paper not relevant to key question
□
2. Other reason
□ (please specify): Checklist completed by:
SECTION 1: INTERNAL VALIDITY In a well conducted RCT study…
In this study this criterion is:
1.1
The study addresses an appropriate and clearly focused question.
Well covered. The aim of study was clearly stated in the introduction.
1.2
The assignment of subjects to treatment groups is randomised
1.3
An adequate concealment method is used
Not reported. Detail of randomization method was not reported, insufficient detail to allow assessment to be made Not addressed. Not mentioned in the study, indicating that this aspect of study design was ignored.
1.4
Subjects and investigators are kept ‘blind’ about treatment allocation
49
Not addressed. Blinding method was not mentioned in the study, indicating that this aspect of study design was ignored.
Adequately addressed. There was no significant statistical difference of the risk factors between two groups such as age, operative time, would classification, or underlying host factors. Adequately addressed. The author allowed other preoperative preparation under the standard guidelines. The only difference between the groups was the preoperative skin antiseptic preparation which is the intervention under study. Adequate addressed. An incisional surgical site infection had occurred if a surgical wound drained purulent materials or if the surgeon judges it to be infected and open it. Specimens collected to laboratory analysis. Not mentioned.
1.5
The treatment and control groups are similar at the start of the trial
1.6
The only difference between groups is the treatment under investigation
1.7
All relevant outcomes are measured in a standard, valid and reliable way
1.8
What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?
1.9
All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)
Not addressed. Intention-to-treat analysis was not mentioned.
1.10
Where the study is carried out at more than one site, results are comparable for all sites
Not applicable. Study was conducted at a single site.
SECTION 2: OVERALL ASSESSMENT OF THE STUDY 1Methods of randomization, blinding, concealment and intention-to-treat were not mentioned in the study. No. Given the above potential biases, study results could not be solely attributed to study intervention.
2.1
How well was the study done to minimise bias? Code ++, +, or
2.2
Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
2.3
Are the results of this study directly applicable to the patient group targeted by this guideline?
2.4
Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question.
Yes.
- The authors demonstrated that pharmacologic action against gram-positive organism of chlorhexidine might be superior to povidone iodine. Wound infection could be decreased from 3.2% to 2% after chlorhexidine skin preparation. - However, chlorhexidine skin preparation could not totally prevent infection caused by gramnegative bacilli or anaerobic organism such as Enterobacter in appendectomy and gastrectomy. - Color staining and hypersensitivity are another disadvantage of povidone iodine solution.
50
Appendix V.Estimated set up cost of the new guideline Estimated set up cost of the new guideline (6-month-period) Manpower Cost Items Project director
3 Project leaders
6 Project coordinator
91 Nursing staff
Item Dscription
Item Cost
Department manger 2 meetings with project coordinators Final evalaution and approval Senior nursing staffs 3 meeting with project director 3 meeting with project committee 1 informative talk to project committee Data analysis and evaluation Moderalty senior nursing staff 3 meeting with project leader 1 informative talk 1 training session to group members All other nursing staffs 1 training sesseion
Total Cost
Salary: $312/hour $312 x 2 hrs x 2 = $1248 $312 x 2 hrs x 1 = $624 $1,872 Salary: $238/hour $238 x 3 x 2 hrs x 3 times =$4284 $238 x 3 x 2 hrs x 3 times =$4284 $238 x 3 x 2 hrs x 1 time =$1428 $238 x 3 x 2 hrs x 1 time =$1428 $11,424 Salary: 214/hour $214 x 6 x 2 hrs x 3 times = $7704 $214 x 6 x 1 hrs x 1 times = $1284 $214 x 6 x 1hrs x 1 times = $1284 $10,272 Salary: $142/hour $214 x 91 x 1 hrs x 1 time = $19474 $19,747 Subtotal estimated cost (HKD): $43,315
Material Cost Items Equipment
Staff Training
Promotion
Item Dscription
Item Cost
Cost of 2% chlorhexidine in 70% alcohol solution = $305/500ml Cost of povidone iodine solution =$274.7/500ml Photocopying & Printing cost Venue & equipments Computers and computer software Email 5 posters
Total Cost
Extra cost required: $30.6 $30.6 x 360/month x 6 $66,096 Hospial provision Hospial provision Hospial provision Hospial provision $50 x 5
$0 $250
Subtotal estimated cost (HKD): $66346
Total estimated cost (HKD): $ 109,661
51
Appendix VI. Estimated saving from the new guideline Estimated saving from the new guideline (6-month-period) Healthcare saving Items Reduced surgical site infection
Item Dscription
Item saving
No. of surigcal cases/month: 1440 Open surgery: 65% Adult patients: 97% No. of taget population/month: 1440 x 65% x 97% = 908
Saving/surgical case: $16–$26(USD) (Lee et al, 2010) Rate: $1USD=$7.75HKD (9/12/2012)
$16 x $7.75 x 908 x 6mth = $675,552 $26 x $7.75 x 908 x 6mth = $1,097,772 Subtotal estimated cost (HKD): $675,552 - $1,097,772
Potential hidden saving Items Evacuation of beds
Decreased extra-manpower
Staff training for higher standard Promotion and advertisment
Item Dscription Reduction of postoperaive surigcal site reduces patient hosptital stay. Free beds can be reserved for new patient admission. Extra manpower is not necessary for handling reopen cases which is reulted from posoperative surgical site infection. Staffs are trained by direct interraction and cooperation, effective communication and leadership skills can be enhanced. Implementation of evidence-based protocol raises the nursing care of the hospital, which in turn help the building up of hospital image.
Item Saving Not estimated
Not estimated
Not estimated
Not estimated
Total estimated cost (HKD): $675,552 - $1,097,772
52
Appendix VII. The evidence-based guideline
An Evidence-based Protocol: Using 2%chlorhexidine in 7-% alcohol in preoperative skin preparation to reduce surgical site infection in adult patients undergoing general surgery 1st Edition on 8 December 2012 by Erica Lai (RN) I. INTRODUCTION Background The Centers for Disease Control and Prevention reported that surgical site infections made up 14% to 16% of all infections and it is the third most frequently reported hospitalacquired infection worldwide (Centers for Disease Control and Prevention, 2009). Surgical site infection not only brings morbidity and mortality to patients, but also substantial financial burden to the hospital and the whole healthcare system. Perioperative nurse plays an important role in minimizing the incidence of surgical site infection by rigorous adherence to aseptic techniques and also fast response to the most updated evidence-based practice. In recent year, extensive studies have investigated chlorhexidine on its stronger antiseptic power over povidone iodine (Munoz-Price et al, 2012).In view of this, it is an inevitable need to develop an evidence-based protocol of preoperative skin preparation by chlorhexidine in order to reduce the incidence of postoperative surgical site infection. Aim The aimof the protocol is to summarize the best available evidence concerning the use of chlorhexidine in preoperative skin preparation. The recommendations developed serve as guidelinein clinical practice to reduce the incidence of surgical site infection in patients undergoing general open surgery.
53
Intended users
Hospitals
Operating department
Surgeons
Theater nurses
Operation assistant
Target Population
Adult surgical patients over 18 year-old undergoing general open operations
II. METHODOLOGY For identification of studies, electronic databases including Medline, PubMed and CINHAL were systematically searched in July 2012 with keywords “chlorhexidine Studies were limited to human species, adults aged 18 or above and randomized control trial.”, “povidone iodine” and “surgical wound infection”. There were totally 5 studies selected finally, including 4 eligible studies yielded from the database search together with one from manual search of the systematic review. All included studies were evaluated by a critical appraisal tool established by the Scottish Intercollegiate Guidelines Network (SIGNS, 2012). Among them, one study demonstrated high methodological quality (Darouiche et al., 2010), three demonstrated moderate methodological quality (Berry et al., 1982; Brown et al, 1984; Sistla et al., 2010) and only one study demonstrated low quality methodology (Paocharoen et al., 2009). The following recommendations are extracted from the critically reviewed studies. Each recommendation is carefully assessed by the grading system developed by the Scottish Intercollegiate Guidelines Network (SIGNS, 2012) in order to show its strength of supporting evidence. However, it does not reflect the clinical importance of the recommendation.
54
III. RECOMMENDATION Recommendation 1 Chlorhexidine-alcohol should be the first consideration for preoperative skin preparation. Grade of recommendation: A Evidence: All reviewed study reported reduced incidence of postoperative surgical site infection was significantly lower in patients prepared with chlorhexidine than in those prepared with povidone iodine preoperatively (Darouiche et al., 2010) [1++](Berry et al., 1982; Brown et al, 1984; Sistla et al., 2010) [1+](Paocharoen et al., 2009)[1-].
Recommendation 2 Nursing assessment should be done on patient and surgical site before skin preparation. Grade of recommendation: A Evidence: Before skin preparation, the surgical site should be assessed for any wound, rash or other skin conditionwhich is high-risk area for colonization by microorganisms. Patient history of allergy reaction should also be checked. If patient had previous experience of chlorhexidine or alcohol hypersensitivity, other choice of antiseptic solution may have to consider(Darouiche et al., 2010) [1++]. In addition, if hair removal is required, it should be done just before surgery in the operating theater as this is associated with lower risk of surgical site infection (Sistla et al., 2010) [1+]
Recommendation 3 The application method of chlorhexidine-alcohol is simply painting for 2 times. Grade of recommendation: A
55
Evidence: The application method of antiseptic solution in preoperative skin preparation varies among studies. Three of the reviewed studies used scrubbing followed by painting (Darouiche et al., 2010)[1++](Brown et al, 1984)[1+] (Paocharoen et al., 2009)[1-], whereas other two studies used simply painting (Berry et al., 1982; Sistla et al., 2010) [1+]. However, the difference in postoperative surgical wound infection between the two methods, painting and scrubbing followed by painting, is not significant (Sistla et al., 2010) [1+]. The first painting is useful in removing the superficial soil and debris from the skin whereas the second painting allows the removal of transient flora and microbes on patient’s skin.Therefore, the usual skin preparation method in the local setting can still be adopted. In a open gerenal surgery preoperatively, the abdomen should be painted with chlorhexidine-alcohol starting from the incision site in a single uniform application.
Recommendation 4 Sufficient time should be allowed to let chlorhexidine-alcohol dry enough before draping. Grade of recommendation: A Evidence: Although some suggested there might be fire hazard when using alcohol-based, product, the reviewed studies stated that chlorhexidine-alcohol was safe to use since no cases of chemical skin burn or fire hazard observed in the operating room in studies. (Darouiche et al., 2010) [1++] The solution should be given adequate time to dry completely before the application of surgical drapes in order to allow adequate time for antimicrobial action of the antiseptic solution and allow complete evaporation of alcohol to prevent sparkling during use of electrosurgical devices (Paocharoen et al., 2009)[1-].
56
Recommendation 5 Use of chlorhexidine-alcohol in spray form Grade of recommendation: B Evidence: A reviewed study suggested that the power of reducing skin bacterial counts of chlorhexidine-alcohol in spray form was equally effective. In addition, The use of spray technique is more convenient and it allows 30 seconds to 10 minutes saved. Thus, this is especially important during emergency situation. (Brown et al, 1984) [1+]
57
IV. REFERENCES Berry, A. R., Watt, B., Goldacre, M.J., Thomson, J.W., & McNair, T.J. (1982). A comparison of the use of povidone-iodine and chlorhexidine in the prophylaxis of postoperative wound infection. Journal of Hospital Infection, 3(1):55-63. Brown, T. R., Ehrlich, C.E., Stehman, F.B., Golichowski, A.M., Madura, J.A., & Eitzen, H.E. (1984). A clinical evaluation of chlorhexidine gluconate spray as compared with iodophor scrub for preoperative skin preparation. A clinical evaluation of chlorhexidine gluconate spray as compared with iodophor scrub for preoperative skin preparation. Surgery Gynecology Obstetric, 158(4):363-6. Darouiche, R.O., Wall, M.J., Itani, K.M.F., Otterson, M.F., Webb, A.L., Carrick, M.M., Miller, H.J., Awad, S.S., Crosby, C.T., Mosier, M.C., AlSharif, A., & Berger, D.H. (2010). Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. New England Journal of Medicine, 362(1):18-26. Paocharoen, V., Mingmalairak, C., & Apisarnthanarak, A. (2009). Comparison of surgical wound infection after preoperative skin preparation with 4% chlorhexidine [correction of chlohexidine] and povidone iodine: a prospective randomized trial. Journal of the Medical Association of Thailand, 92(7):898-902. SIGN. 2012. Evidence table for intervention studies. Retrieved Apr 30, 2012 from http://www.sign.ac.uk/guidelines/fulltext/50/compevidence.html Sistla, S.C., Prabhu, G., Sistla S., & Sadasivan J. (2010). Minimizing wound contamination in a 'clean' surgery: comparison of chlorhexidine-ethanol and povidone-iodine. . Chemotherapy, , 56(4):261-267.
58
Appendix VIII.Timeline and Communication Plan for preparation, pilot, implementation and evaluation
PILOT
PREPARATION
Task / Description Seek Approval - State importance of problem - Explain reason for change Illustrate current evidence - Present proposal - Ask DOM to be project director Project Team Development - Highlight significance of project - 2 more project leaders assigned by DOM - 6 project coordinator assigned by NOs Informative Talk - Highlight significance of project - Brief following tasks and duties Project Planning - Develop promotion plan - Design poster for promotion - Plan training schedule - Prepare training materials and notes - Arrange resources and equipment - Contact Pharmacy Dept. to order chlorhexidine gluconate and reduce the order of betadine - Division of work Promotional Activity - Announce the new guideline - Posters in OT rooms, tea rooms, open areas - Promotion during group meetings - Emails to surgeons Staff Training - Present the significance of the new guideline - Provide training to team members during group meeting Pilot Test - Collect feedback at the end
Project leader
Pilot Test Review - Report pilot result - Discuss findings from pilot study - Share difficulties and challenges - Identify possible solutions for the challenges - Refine the guidelines
Targets Department operative manager
Weeks 1
2
3
4
5
6
7
Month 8
9
10
11
12
1---------------3
-----------------6
---------------12
*
*
*
*
*
*
*
Surgical team head Project leader
Project leaders
Department operative manager Nursing officer Project coordinators
* *
Project leader
Project leaders & coordinators
Project leaders & coordinators
Nursing staffs Surgeons
*
Project coordinators
Nursing staffs
* *
Project leaders & coordinators
Nursing staffs Surgeons
Project leaders
Department operative manager
* * *
* * * * * *
Project coordinators
All nursing staffs Surgeons
Patients
Patient outcomes - SSI, time to infection, grade of infection, pathogen and serum level, complications, length of prolonged hospital stay. Staff outcomes - Knowledge, satisfaction - Compliance, competence and satisfaction
Project coordinators
Patients
Project coordinators
All nursing staffs Surgeons
System outcome Costs Benfits
Project leaders
Hospital
IMPLEMENTATION EVALUATION
Organizer
*
* *
59
Appendix IX.Data collection sheet Evidence-based guidelines for chlorhexidine gluconate Case Number: in preoperative skin preparation to reduce surgical site infection in patients undergoing general surgery
(Patient label)
Data collection sheet PART I: DEMOGRAPHY INFORMATION 1. Gender / Age : M / F / Age: 2. Height / Body Weight : cm / 3. Underlying diseases : 4. Length of preoperative stay : days 5. ASA score : 1 / 2 / 3 / 4 / 5
kg
PART II: PREIOPERATIVE INFORMATION 1. Preoperative diagnosis : 2. Date of operation : 3. Duration of operation : minutes 4. Type of operation : 5. Operating surgeons : (Chief) Dr. , (Assistant) Dr. , Dr. 6. Emergency / elective : Emergency / Elective : No / Yes, please specify: 7. Use of antibiotics prophalysis 8. Skin preparation a) Skin antiseptic solution : CH / PVI / SV / ALH b) Application method : Paint / Scrub / 1 time / 2 times / Other: c) Drying method Allow to dry / Dried by towel d) Contact time : min sec e) Applying staff : (Year of experience: f) Unexpected event : No / Yes, please specify:
)
PART III: POST OPERATIVE INFORMATION 1. SSI developed? : No / Yes 2. Date of SSI diagnosed : 3. Signs and symptoms Fever (>38°C) / Pain / Tenderness / Redness / Swelling / Watery discharge / Pus / Purulent discharge / Abscess 4. Grade of infection : Superficial / Deep / Organ / Sepsis 5. Wound swab taken No / Yes (Date) (Result) 6. Causative pathogens : 7. Bacterial colony-forming units : CFU/ml 8. Reoperation involved : No / Yes (Date) (Operation) 9. Prolonged hospital stay : No / Yes, days 10. Complication r/t solution : No / Skin allergy / Staining / Others: REMARKS
60
Appendix X.Staff survey Evidence-based guidelines for chlorhexidine gluconate in preoperative skin preparation to reduce surgical site infection in patients undergoing general surgery Staff survey Dear all, We would like to know your comments about the the new guideline: Use of chlorhexidine gluconate in preoperative skin preparation. Please circle the appropriate number to show your level of satisfaction.
1.
Comments I think the training session is useful.
2.
I understand the reason for the new guideline.
3.
I think the guideline improves quality of care.
4.
I think the training increase my knowledge on the new evidence on preoperative skin preparation. I am willing to follow the new guideline.
5. 6.
Least agree
8.
I can demonstrate preoperative skin preparation with proper skills as indicated in the new guideline. I am confident in encouraging surgeons with the use of chlorhexidine gluconate for skin preparation in open surgery. I gain enough assistance from the project team.
9.
I think the new guideline adds more workload to me.
10.
In general, I am satisfied with the new guideline.
11.
Any other comments / difficulties / suggestions?
7.
Sex: Year of experience: Ranking:
M / F 0-3 / 4-6 / 7-9 / >10 EN / SN / SSN / NS / WM 61
Most agree
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
1
2
3
4
5
REFERENCES
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surgery:
comparison
of
chlorhexidine-ethanol
and
povidone-iodine.
.
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