Standard abdominal wound edge protection with surgical dressings vs coverage with a sterile circular polyethylene drape for prevention of surgical site infections (BaFO): study protocol for a randomized controlled trial
© Mihaljevic et al.; licensee BioMed Central Ltd. 2012
Received: 14 September 2011
Accepted: 9 March 2012
Published: 15 May 2012
Postoperative surgical site infections cause substantial morbidity, prolonged hospitalization, costs and even mortality and remain one of the most frequent surgical complications. Approximately 14% to 30% of all patients undergoing elective open abdominal surgery are affected and methods to reduce surgical site infection rates warrant further investigation and evaluation in randomized controlled trials.
To investigate whether the application of a circular plastic wound protector reduces the rate of surgical site infections in general and visceral surgical patients that undergo midline or transverse laparotomy by 50%. BaFO is a randomized, controlled, patient-blinded and observer-blinded multicenter clinical trial with two parallel surgical groups. The primary outcome measure will be the rate of surgical site infections within 45 days postoperative assessed according to the definition of the Center for Disease Control. Statistical analysis of the primary endpoint will be based on the intention-to-treat population. The global level of significance is set at 5% (2 sided) and sample size (n = 258 per group) is determined to assure a power of 80% with a planned interim analysis for the primary endpoint after the inclusion of 340 patients.
The BaFO trial will explore if the rate of surgical site infections can be reduced by a single, simple, inexpensive intervention in patients undergoing open elective abdominal surgery. Its pragmatic design guarantees high external validity and clinical relevance.
http://www.clinicaltrials.gov NCT01181206. Date of registration: 11 August 2010; date of first patient randomized: 8 September 2010
KeywordsAbdominal dressing Abdominal surgery Randomized trial Surgical site infection Wound edge protector Wound infection
Rationale for the trial
Postoperative surgical site infections (SSIs) are one of the most frequent surgical complications and a major cause of postoperative morbidity, prolongation of hospital stay, healthcare costs and even mortality. An estimated 300,000 to 500,000 SSIs occur in the USA annually [1–4]. In Germany SSIs are the third most frequent cause of nosocomial infections and account for approximately 15% of the 400,000 to 600,000 nosocomial infections per year (60,000 to 90,000 cases) according to data from the Robert-Koch Institute (RKI) and the German Nationales Referenzzentrum für Surveillance von Nosokomialen Infektionen (NRZ) [5, 6]. Data from the German Krankenhaus Infektions-Surveillance-System (KISS) estimate an even higher number of approximately 128,000 SSIs annually . Furthermore, an estimated 7,500 to 15,000 patients die every year in Germany due to nosocomial infections [7, 8].
Despite the implementation of preventive measures such as preoperative antibiotic prophylaxis [9–12] and antiseptic skin cleansing [9, 13], SSI rates in prospective trials with adequate follow-up and standardized SSI definition in abdominal surgical patients remain high and vary from 14% to 32% [14–17]. Applying the SSI criteria of the Center for Disease Control (CDC) , which differentiate between superficial, deep and organ-space SSIs at postoperative day 30, Darouiche et al. reported an overall SSI rate of 16.1% in the control group (povidone-iodine skin preparation) of their randomized controlled trial (RCT) in patients with clean-contaminated abdominal surgery . Seiler et al. reported similar numbers in a randomized multicenter trial comparing three different techniques of abdominal wall closure in abdominal surgical patients with SSI rates varying from 13% to 19% . SSI rates following colorectal surgery seem to be even higher as was shown by Bennett-Guerrero and colleagues, who reported an overall SSI rate of 21% in the control group (and 30% in the intervention group) of their prospective multicenter RCT comparing the application of a gentamicin-collagen sponge versus no intervention in colorectal patients . National data from the USA support these numbers .
Multiple studies have shown an increase in the mean length of hospital stay by 6 to 24 days if SSIs occur [4, 22–25]. The resulting direct costs have to be added to the indirect costs such as loss of workforce or insurance payments resulting in substantial expenses for the healthcare system [26–28].
The most frequent pathogens causing postoperative SSIs in general and abdominal surgical patients are endogenous pathogens from the skin or gastrointestinal tract (KISS data 2005 to 2008, ). This implies that adequate protection of the surgical site by wound edge protectors might reduce the rate of postoperative SSIs.
Several previous trials have investigated the effect of wound edge protectors on SSI rates in abdominal surgery and report mixed results. While some found beneficial effects [30–33] others reported no benefit [34–36]. Similarly, a randomized trial in 2011 in which wound protectors were introduced together with other measures as a bundle to reduce SSIs did not show a benefit . The diverging results may be explained by trial design, since the mentioned trials were either performed in a single institution setting, had small sample sizes, lacked adequate blinding, standardization or used varying definitions of outcome variables (SSI definitions). Large multicenter randomized trials comparing the use of a wound edge protector with standard intervention (sterile towels) under standardized conditions and with defined outcome variable (CDC definition of SSIs) are lacking.
BaFO aims to investigate whether the application of a circular plastic wound edge protector (Figure 1) reduces the rate of SSIs (within 45 days postoperatively) in abdominal surgical patients that undergo elective midline or transverse laparotomy by 50% (from 16% to 8%). As a secondary endpoint the difference in intraoperative core body temperature between the two study groups will be evaluated.
The BaFO trial will be performed at 15 sites of the Trial Network (CHIR-Net) of the German Surgical Society (Deutsche Gesellschaft für Chirurgie (DGCH)). Most of these sites have participated in previous randomized controlled trials and all centers were adequately trained and prepared according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)-good clinical practice (GCP) rules for participation in this trial. CHIR-Net is funded by the German Ministry of Research and Education (Bundesministerium für Bildung und Forschung (BMBF); see funding information below).
Trial population and eligibility criteria
Exclusion criteria of the BaFO trial
ASA grade >3
Pregnant or lactating women
Midline or transverse laparotomy within the last 60 days prior to trial intervention
Planned relaparotomy within 30 days after trial intervention
Contaminated operations according to CDC definition 
Small abdominal operations without planned transverse or midline laparotomy (for example, appendectomy)
Concurrent abdominal wall infections
Severe immunosuppression, for example after: organ or bone marrow transplantation, concurrent steroid treatment with >10 mg prednisone daily (or an equivalent dose of any other steroid), concurrent infliximab treatment or treatment with an equivalent immunosuppressive substance, or chemotherapy within the last 2 weeks prior to trial intervention
Severe preoperative neutropenia (≤0.5 × 109 cells/l)
Liver cirrhosis; Child-Pugh B or C 
A total of 258 patients will be analyzed per group. Given an estimated drop out rate of approximately 15%, 600 patients will be randomized to 1 of the 2 treatment arms.
Type of trial
Randomized, controlled, observer and patient blinded multicenter surgical trial with two parallel comparison groups.
Recruitment and trial timeline
A total of 15 centers of general and abdominal surgery in Germany will participate in this trial. The centers vary from university hospitals to community hospitals and include certified centers for colorectal surgery (Darmzentren). All centers are members of the Trial Network (CHIR-Net) of the German Surgical Society. Physicians or nurses involved in the trial have been trained in ICH-GCP prior to initiation of the trial. Furthermore, all centers and participants were specifically instructed in study-specific procedures prior to the start of the trial. The centers will be supported by an ICH-GCP qualified flying study nurse from the CHIR-Net Surgical Regional Centre Munich to ensure protocol conforming data acquisition and trial interventions. Stratification according to center will be performed and all centers must recruit a minimum of 15 patients.
Randomization and blinding
Randomization and blinding will be performed with the help of sealed, opaque, individually numbered envelopes, restricted to choosing one at a time. The envelopes contain data sheets with information regarding the group allocation and the randomization number. Both will be prefabricated by a biostatistician of the Technische Universität München (TUM; Munich, Germany). Randomization (visit 2, see Figure 2) will be performed after inclusion of the patient in the trial (informed consent, visit 1) or in the period between inclusion and the trial intervention (day of surgery) or at the day of surgery (visit 3). Randomization will be performed stratified by center. To assure balanced group sizes in the course of the accrual, a blockwise randomization is applied. Basic characteristics of the patient and day of randomization must be documented on the randomization sheets. Subsequently, randomization sheets must be dated, signed and stored away from the patient records, the trial documents and the investigator site file to ensure blinding. Patients, outcome assessors and the trial statistician will be blinded for the trial intervention. The outcome assessor (postoperative SSIs) will therefore neither be part of the surgical team that performs the trial intervention nor have access to the randomization sheets. Patients will be blinded since they are under general anesthesia during the operation and therefore will not be aware which intervention is used during the operation.
Experimental intervention: all elective general or abdominal surgical patients undergoing a midline or transverse laparotomy for any cause will have their surgical incisions covered with a circular sterile plastic wound edge protector during the operation (see Figure 1).
Control intervention: draping of the surgical incision will be performed with standard sterile surgical dressings.
Study visits of the BaFO trial
Visit 1 (screening)
Visit 2 (randomization)
Visit 3 (operation)
Visit 4 (postop day 2)
Visit 5 (postop day 4)
Visit 6 (postop day 6)
Visit 7 (postop day 8)
Visit 8 (postop days 10 to 14)
Visit 9 (postop days 30 to 45)
Demographics and baseline clinical data
Patient information and informed consent
Measurement of wound diameter
No additional risks for study patients are anticipated, since the application of a circular sterile plastic wound edge protector represents a clinically established standard method. The wound edge protector used in BaFO is CE certified (3 M Steri-Drape Wound Edge Protector, 3 M, St. Paul, MN, USA). All surgical procedures carried out within BaFO are not affected by the trial.
Primary efficacy endpoint of the BaFO trial is the rate of SSIs according to Center for Disease Control (CDC) criteria, which constitutes the internationally accepted standard definition within 45 days postoperatively . Secondary outcome measure is the intraoperative core body temperature measured at the beginning, in the middle and at the end of the operation via nasal, rectal, transurethral or central venous probes. Temperature as well as the modality of measurement will be recorded.
All required information collected during the trial is entered in the case record form (CRF) by the investigator or a designated representative. Documentation is expected to be completed as soon as possible after the information has been collected. The investigator is responsible for the accuracy of the documentation and must ensure that all entries can be verified by source data. An explanation must be given for all missing data. Corrections in the CRF must be signed, dated and leave the corrected entry visible. The completed CRF must be reviewed, signed and dated by the investigator named in the trial protocol or by a designated subinvestigator. After keeping a copy at the trial center, the original CRF is sent in a sealed envelope by certified mail to the Centre for Data Management at the Münchner Studienzentrum (MSZ; member of the Network of Coordinating Centres for Clinical Trials (KKS Network) at the Technische Universität München, Munich, Germany). Double data entry is performed by data management according to standard operating procedures predefined in the data management plan to ensure correct transfer of data from the CRF to the database (hardware: Windows Server NT 2003 (Microsoft, Redmond, WA, USA); software: MACRO™ V.3, Microsoft SQL Database (Microsoft, Redmond, WA, USA); browser: Microsoft Internet Explorer V.6 or higher (Microsoft, Redmond, WA, USA)). Completeness, validity and plausibility of data are examined by validating programs as well as individual inspection and queries are generated accordingly which need to be clarified by the investigator or designated subinvestigator. At the end of the trial the principal investigator will retain the original CRFs.
Monitoring of the trial data will be performed by an independent institution experienced in the monitoring of surgical trials (KKS Network) at the TUM (Münchner Studienzentrum). Monitoring will be carried out in accordance with ICH-GCP guidelines  and standard operating procedures of the MSZ to ensure patients´ safety and integrity of the clinical data, for example, primary outcome measure in adherence to study protocol. All trial sites are activated with an initiation visit by the monitor or CHIR-Net coordinator, who will hand out and explain the investigator site file, discuss relevant issues and train trial personnel in study-specific interventions. Regular contact by phone or email with all participating centers will enable the CHIR-Net Coordinator and the monitor to control the study progression, adherence to the study protocol, and to discuss problems related to the study. Regular on-site monitoring visits are planned for all sites. Investigators must allow the monitor to look at all essential documents, support the monitor during visits and answer queries. All monitoring procedures will be predefined in a trial-specific monitoring manual. In addition, a GCP-trained flying study nurse employed by the CHIR-Net regional center Munich will assist the trial sites with documentation and data collection if needed. Furthermore, close-out visits are planned for each center.
Safety evaluation and reporting of adverse events
Occurrence of the primary endpoint is assessed as endpoint only (not as adverse event).
The following conditions are expected after the initial operation and will therefore not be classified as adverse events: pain, nausea, vomiting, urinary tract infection, hyper/hypotension, imbalances of blood sugar or electrolytes and other lab values out of range, if they do not exceed grade 3 to 4 in the Common Terminology Criteria for Adverse Events version 3.0 . Assessment will be performed by the investigator or the designated subinvestigator.
From the day the patient has signed informed consent until the regular end of the trial (visit 9) or until premature withdrawal of the patient, all serious adverse events (SAEs) will be documented on a ‘serious adverse events form’ available in the investigator site file. An SAE will be defined as an event, that results in death, is immediately life threatening, requires or prolongs hospitalization or results in persistent or clinically important disability or incapacity as judged by the investigator or designated subinvestigator. SAEs will be classified to intensity (mild, moderate, severe), outcome (ongoing, recovered completely, recovered with sequelae, death, unknown) and causality (unrelated; possibly, probably or definitely related to trial intervention; not assessable). The assessment is based on clinical findings and needs to be performed by the investigator or designated subinvestigator in the participating trial centers. SAEs will have to be reported within 7 days after becoming known.
Sample size calculation
Sample size calculation is based on the primary end point of surgical site infections within 45 days post operation according to the CDC classification  and was conducted by using nQuery Advisor software version 7.0 (Statistical Solutions Ltd, Cork, Ireland). Based on the assumption that the percentage of patients developing postoperative wound infections in a mixed surgical population undergoing midline or transverse laparotomy is approximately 16% for the standard group (control group, see Background) and can be reduced to 8% in the experimental intervention arm, a group sample size of 258 patients would need to be compared by the χ2 test, to achieve 80% power in detecting this difference in SSI rate at a 2-sided level of significance of 5%. Analysis of the primary efficacy endpoint will be based on a χ2 and not based on a random effects model, which would assume different underlying effects within the centers. However a generalized linear mixed effect model (logit link regression) will be fitted to the data in terms of a supportive sensitivity analysis that allows for assessment of the primary efficacy endpoint under consideration of random center effects. Under the assumption of a dropout rate of up to 15%, a total of 600 patients would need to be enrolled in the study. Due to the broad inclusion criteria, the limited number of exclusion criteria, the limited time frame as well as the comprehensible nature of the trial, no more than 200 patients are expected to be screening failures, which brings the total number of patients that need to be screened for eligibility to 800 (Figure 2).
Based on the multicenter trail design, stratification according to recruiting center will be used . Each participating center will have to enroll a minimum of 15 patients. Centers with fewer than 15 patients will be excluded from the primary efficacy analysis. Therefore, recruitment will be continued until enough centers lead to the required total sample size by each enrolling a sufficient number of patients.
The primary analysis will be conducted according to the intention-to-treat (ITT) principle, that is, all included patients will be analyzed as randomized. Patients with missing primary outcome data will be considered as non-SSI cases if they belong to the control group and as SSI cases if they were randomized to the innovative treatment arm. For purpose of sensitivity analyses, per protocol and complete case analyses of the primary endpoint will be conducted and further appropriate and less conservative missing-value replacement strategies such as multiple conditional imputation  will be employed.
A planned interim analysis will be performed after recruitment and follow-up of 340 patients (two-thirds of the planned total). Due to this intended interim analysis, global α error adjustment is performed by the method of O’Brien and Fleming . Therefore, evaluation of the primary efficacy endpoint will be conducted at a 0.005 level of significance (two sided) in the interim analysis and at a 0.048 level of significance (two sided) in the final statistical analysis.
Prespecified subgroup analyses or treatment group comparisons will be performed for: rate of superficial postoperative SSIs (according to CDC classification); rate of deep postoperative SSIs (according to CDC classification); rate of postoperative SSIs of organ space (according to CDC classification); rate of postoperative SSIs (total/superficial/deep/organ space) stratified by the National Nosocomial Infection Surveillance (NNIS) risk score ; rate of postoperative SSIs (total/superficial/deep/organ space) stratified by colorectal and non-colorectal operations.
Secondary analyses will be conducted in an explorative manner. Kaplan-Meier analysis and Cox regression analyses will be employed for analyses of time to event endpoints. The χ2 test will be used to compare frequency data between intervention groups. As appropriate, the Student t test, Mann–Whitney U test or analysis of covariance (ANCOVA) will be employed for group comparisons of quantitative data. The 95% confidence intervals will be provided for estimates of relevant effect sizes.
Safety analysis includes description and comparison of the frequency of adverse and serious adverse events in the two intervention groups.
Procedures for the statistical analysis of the primary and secondary endpoints will be conducted in line with the ICH-GCP E9 guideline . For the statistical analysis, SAS® software version 9.2 or higher will be used (SAS Institute Inc., Cary, NC, USA). The statistical analysis will be performed by a group-allocation-blinded statistician from the Institute for Medical Statistics and Epidemiology of the TUM.
Patients are free to withdraw trial participation at their own request at any time and without giving reasons for their decision. Withdrawals will be documented in the CRF and in the patient´s medical record. Furthermore, all ongoing SAEs have to be followed-up and documented until their final outcome can be determined.
The trial can be prematurely closed by the coordinating investigator in consultation with the responsible biostatistician for the following reasons: the planned interim analysis indicates that rate or severity of SAE/morbidity in this trial poses a potential health hazard caused by the trial treatment in one or both of the trial groups; it appears that patients' enrolment is unsatisfactory with respect to quality or quantity or data recording is severely inaccurate or incomplete; external evidence demanding a termination of the trial.
In case of premature closure, the ethics committee has to be informed.
Trial organization and administration
The Trial Network CHIR-Net of the German Surgical Society (DGCH) is funded by the German Ministry of Research and Education (Bundesministerium für Bildung und Forschung (BMBF); 01GH0702). The circular polyethylene wound protector (Steri-Drape Wound Edge Protector) used in the BaFO trial is provided by 3 M Infection Prevention Division (3 M Medica, 3 M Deutschland GmbH, Neuss, Germany). No financial support is given other than the funding by the BMBF mentioned above (01GH0702). There are no restrictions on publications and no conflict of interest. The idea for the BaFO trial was conceived, the trial protocol written and the trial initiated independent of the any industrial funder. Industrial funders and trial management are independent.
Before the start of the trial, the trial protocol, informed consent document and any other trial documents were submitted to the independent ethics committee on 7 June 2010. Ethics approval was granted on 22 June 2010. A major protocol amendment was submitted to the ethics committee on 18 November 2010 and was approved 1 December 2010.
The trial protocol was registered at http://www.clinicaltrials.gov and was given the number NCT01181206.
Good clinical practice
The procedures set out in this trial protocol, pertaining to the conduct, evaluation and documentation of this trial, are designed to ensure that all persons involved in the trial abide by Good Clinical Practice  and the ethical principles described in the current revision of the Declaration of Helsinki . The trial will be carried out in keeping with local legal and regulatory requirements.
Definitions of abdominal surgical site infections (SSIs) classified according to the Centers for Disease Control and Prevention
Superficial incisional SSI:
Infection occurs within 30 days after the operation AND
Infection involves only skin or subcutaneous tissue of the incision AND
At least one of the following:
A. Purulent drainage, with or without laboratory confirmation, from the superficial incision
B. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
C. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture negative
D. Diagnosis of superficial incisional SSI by the surgeon or attending physician
Deep incisional SSI:
Infection occurs within 30 days after the operation AND
Infection involves deep soft tissues (for example, fascial and muscle layers) of the incision AND
At least one of the following:
A. Purulent drainage from the deep incision but not from the organ/space component of the surgical site
B. A deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs or symptoms: fever (>38°C), localized pain, or tenderness, unless site is culture negative
C. An abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination
D. Diagnosis of a deep incisional SSI by a surgeon or attending physician
Notes: (1) report infection that involves both superficial and deep incision sites as deep incisional SSI; (2) report an organ/space SSI that drains through the incision as a deep incisional SSI
Infection occurs within 30 after the operation AND
Infection involves any part of the anatomy (for example, organs or spaces), other than the incision, which was opened or manipulated during an operation AND
At least one of the following:
A. Purulent drainage from a drain that is placed through a stab wounda into the organ/space
B. Organisms isolated from an aseptically obtained culture of fluid or tissue in the organ/space
C. An abscess or other evidence of infection involving the organ/space that is found on direct examination, during reoperation, or by histopathologic or radiologic examination
D. Diagnosis of an organ/space SSI by a surgeon or attending physician
The most frequent pathogens causing postoperative SSIs in general surgical patients are Staphylococcus aureus Escherichia coli and Enterococcus spp. Similarly, in abdominal surgical patients E. coli Enterococcus spp, Enterobacter spp and S. aureus are the most frequent pathogens (KISS data 2005 to 2008, ). These data indicate that endogenous infections from the patients´ skin or the gastrointestinal tract account for most SSIs and that a high number of SSIs might be prevented by adequate coverage of the incisional wound edges during surgical procedures. Wound edge protectors such as the one used in the BaFO trial do not only prevent displacement of skin pathogens into the surgical site such as incisional drapes do, but also effectively protect the skin, subcutaneous tissue, fascia and muscle from spillage of abdominal content during the surgical procedure. In addition, wound edge protectors cover the entire abdomen during the surgical procedure and thus have the theoretical benefit of improved temperature control and prevention of intraoperative hypothermia, a factor associated with SSIs in several studies [52, 53]. We have incorporated this question into the BaFO trial by measuring the intraoperative core body temperature in both groups and analyze the differences as secondary endpoint.
However, wound edge protectors have not yet been rigorously tested in multicenter randomized controlled trials, since the studies available today are either single-center trials, lack clear SSI definitions/endpoints, or only include a small number of patients. Even in the trials available mixed results have been reported. A recent single center trial in elective colorectal patients reported a reduction of SSI rates from 22.7% to 4.7% . Similarly, in a non-randomized single-center prospective trial with 221 patients reported a reduction in SSI rates only for patients undergoing colorectal surgery. Interesting only superficial SSI rates were reduced while rates of organ-space infections remained unchanged . A randomized trial with 352 patients at 2 institutions found a reduction of SSIs from 22.6% to 10.5% with the application of a wound-edge protector in patients with clean/contaminated or contaminated wounds . However, in a report from Psaila et al. wound-edge protection did not reduce SSI rate in abdominal surgery . Similarly, a study by Kercher et al. reported no benefit of wound protectors in patients undergoing laparoscopic-assisted colon surgery , a result that was confirmed for open colorectal surgery by Nyström et al. . Furthermore, several of these trials were underpowered. Taken together these conflicting results disallow a definitive answer whether wound-edge protectors constitute a reasonable approach to reduce SSI rates in general and abdominal surgery.
Hence, sufficient pilot data are available to justify the conduct of a prospective multicenter randomized patient-blinded and observer-blinded trial. Since further single center studies would not increase the external validity (generalizability) a multicenter approach was chosen and the trial was initiated within the Trial Network of the German Surgical Society (CHIR-Net). To further increase external validity broad inclusion criteria and few exclusion criteria are applied allowing for the screening and recruitment of many elective open general and abdominal surgical cases in the participating hospitals. Hospitals of different care levels participate in this trial together underlining the pragmatic approach of the trial. For many participating surgical departments SSIs represent the most frequent postoperative complication and thus a pressing surgical question that remains to be solved. To ensure data quality members of all participating centers are trained in GCP guidelines, trial intervention, documentation and blinding. In addition, internal validity is ensured by patient-blinding and observer-blinding, application of definite endpoints (SSI definition by the CDC) and complete outcome reporting and follow-up. Applying high methodological standards the results of the trial should help to improve surgical treatment of patients.
As of 29 February 2012 a total of 323 patients had been recruited to the trial.
The following centers of the CHIR-Net study group participate in the BaFO trial: Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Munich, Germany (H Friess, J Kleeff, AL Mihaljevic, CW Michalski, M Erkan, C Reiser-Erkan, C Jäger, C Schuhmacher, T Schuster); Sozialstiftung Bamberg (C Hahn, A Fischer); Ilmtalklinik Pfaffenhofen (R Lange, L Behforouzi-Sabic, E Engelhard, S Roth, T Harzenetter); Städtisches Klinikum Schwabing (H Waldner, M Rudolph); RoMed Klinik Prien am Chiemsee (J Stadler, K-W Henkel); Maria-Theresia Klinik München (T Hoffmann, I Assman, C Orlitsch); Klinikum Freising (E Nägele, F Zeller, A Hiebinger); Klinikum Garmisch-Partenkirchen (H Vogelsang, A Brandl, B Halve); Klinikum Landshut-Achdorf (J Schmidt, H Dietz, M Kasior); Klinikum Harlaching (O Hekeler, R Kopp); Klinikum St. Marien Siegen (F Willeke, A Hees, R Strunk); Klinikum St. Elisabeth Straubing (R Obermaier, R Unger, M Krug); Klinikum Bogenhausen (W Heitland, F Glass, M Michalski); Kliniken Nordoberpfalz AG Weiden (K-H Dietl, H Hagen, K Müller); Rot-Kreuz-Klinikum München (MH Schoenberg).
- Hawn MT, Itani KM, Gray SH, Vick CC, Henderson W, Houston TK: Association of timely administration of prophylactic antibiotics for major surgical procedures and surgical site infection. J Am Coll Surg. 2008, 206: 814-819. 10.1016/j.jamcollsurg.2007.12.013.View ArticlePubMedGoogle Scholar
- Belda FJ, Aguilera L, de la García-Asunción J, Alberti J, Vicente R, Ferrándiz L, Rodríguez R, Company R, Sessler DI, Aguilar G, Botello SG, Ortí R: Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005, 294: 2035-2042. 10.1001/jama.294.16.2035.View ArticlePubMedGoogle Scholar
- Kurz A: Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008, 22: 39-62. 10.1016/j.bpa.2007.10.004.View ArticlePubMedGoogle Scholar
- Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ: The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999, 20: 725-730. 10.1086/501572.View ArticlePubMedGoogle Scholar
- Gastmeier P, Brunkhorst F, Schrappe M, Kern W, Geffers C: How many nosocomial infections are avoidable? [in German]. Dtsch Med Wochenschr. 2010, 135: 91-93. 10.1055/s-0029-1244823.View ArticlePubMedGoogle Scholar
- Geffers C, Rüden H: Gesundheitberichterstattung des Bundes, Nosokomiale Infektionen. [http://www.gbe-bund.de/gbe10/ergebnisse.prc_tab?fid=7845&suchstring=Heft_8&query_id=&sprache=D&fund_typ=TXT&methode=2&vt=1&verwandte=1&page_ret=0&seite=&p_lfd_nr=1&p_news=&p_sprachkz=D&p_uid=gast&p_aid=71600403&hlp_nr=3&p_janein=J]
- Geffers C, Sohr D, Gastmeier P: Mortality attributable to hospital-acquired infections among surgical patients. Infect Control Hosp Epidemiol. 2008, 29: 1167-1170. 10.1086/592410.View ArticlePubMedGoogle Scholar
- ECDC: Annual epidemiological report on communicable diseases in Europe. [http://ecdc.europe.eu/health_topics/HCAI]
- Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR: Guideline for prevention of surgical site infection, Centres for Disease Control and Prevention (CDC) hospital infection control practices advisory committee. Am J Infect Control. 1999, 1999 (27): 97-132.View ArticleGoogle Scholar
- Page CP, Bohnen JM, Fletcher JR, McManus AT, Solomkin JS, Wittmann DH: Antimicrobial prophylaxis for surgical wounds. Guidelines for clinical care. Arch Surg. 1993, 128: 79-88. 10.1001/archsurg.1993.01420130087014.View ArticlePubMedGoogle Scholar
- Bratzler DW, Houck PM: Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Am J Surg. 2005, 189: 395-404. 10.1016/j.amjsurg.2005.01.015.View ArticlePubMedGoogle Scholar
- Dellinger EP, Gross PA, Barrett TL, Krause PJ, Martone WJ, McGowan JE, Sweet RL, Wenzel RP: Quality standard for antimicrobial prophylaxis in surgical procedures. The Infectious Diseases Society of America. Infect Control Hosp Epidemiol. 1994, 15: 182-188. 10.1086/646887.View ArticlePubMedGoogle Scholar
- Napolitano LM: Decolonization of the skin of the patient and surgeon. Surg Infect. 2006, 7 (Suppl 3): 3-15.Google Scholar
- Itani KMF, Wilson SE, Awad SS, Jensen EH, Finn TS, Abramson MA: Ertapenem versus cefotetan prophylaxis in elective colorectal surgery. N Engl J Med. 2006, 355: 2640-2651. 10.1056/NEJMoa054408.View ArticlePubMedGoogle Scholar
- Milsom JW, Smith DL, Corman ML, Howerton RA, Yellin AE, Luke DR: Double-blind comparison of single-dose alatrofloxacin and cefotetan as prophylaxis of infection following elective colorectal surgery. Trovafloxacin Surgical Group. Am J Surg. 1998, 176 (Suppl): 46-52.View ArticleGoogle Scholar
- Arnaud JP, Bellissant E, Boissel P, Carlet J, Chastang C, Lafaix C, Rio Y, Berganeschi R: Single-dose amoxycillin-clavulanic acid vs. cefotetan for prophylaxis in elective colorectal surgery: a multicentre, prospective, randomized study. The PRODIGE Group. J Hosp Infect. 1992, 22 (Suppl A): 23-32.View ArticlePubMedGoogle Scholar
- Smith RL, Bohl JK, McElearney ST, Friel CM, Barclay MM, Sawyer RG, Foley EF: Wound infection after elective colorectal resection. Ann Surg. 2004, 239: 599-605. 10.1097/01.sla.0000124292.21605.99.View ArticlePubMedPubMed CentralGoogle Scholar
- Darouiche RO, Wall MJ, Itani KMF, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH: Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. N Engl J Med. 2010, 362: 18-26. 10.1056/NEJMoa0810988.View ArticlePubMedGoogle Scholar
- Seiler CM, Bruckner T, Diener MK, Papyan A, Golcher H, Seidlmayer C, Franck A, Kieser M, Büchler MW, Knaebel H-P: Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicentre randomized trial (INSECT: ISRCTN24023541). Ann Surg. 2009, 249: 576-582. 10.1097/SLA.0b013e31819ec6c8.View ArticlePubMedGoogle Scholar
- Bennett-Guerrero E, Pappas TN, Koltun WA, Fleshman JW, Lin M, Garg J, Mark DB, Marcet JE, Remzi FH, George VV, Newland K, Corey GR: Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. N Engl J Med. 2010, 363: 1038-1049. 10.1056/NEJMoa1000837.View ArticlePubMedGoogle Scholar
- Auerbach AD: Prevention of surgical site infections. Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Evidence Report/Technology Assessment. 2001, Rockville, MD, USA: Agency for Healthcare Research and Quality, 221-244.Google Scholar
- Coello R, Glenister H, Fereres J, Bartlett C, Leigh D, Sedgwick J, Cooke EM: The cost of infection in surgical patients: a case–control study. J Hosp Infect. 1993, 25: 239-250. 10.1016/0195-6701(93)90110-L.View ArticlePubMedGoogle Scholar
- Kappstein I, Schulgen G, Fraedrich G, Schlosser V, Schumacher M, Daschner FD: Added hospital stay due to wound infections following cardiac surgery. Thorac Cardiovasc Surg. 1992, 40: 148-151. 10.1055/s-2007-1020134.View ArticlePubMedGoogle Scholar
- Poulsen KB, Bremmelgaard A, Sørensen AI, Raahave D, Petersen JV: Estimated costs of postoperative wound infections. A case–control study of marginal hospital and social security costs. Epidemiol Infect. 1994, 113: 283-295. 10.1017/S0950268800051712.View ArticlePubMedPubMed CentralGoogle Scholar
- Merle V, Germain JM, Chamouni P, Daubert H, Froment L, Michot F, Teniere P, Czernichow P: Assessment of prolonged hospital stay attributable to surgical site infections using appropriateness evaluation protocol. Am J Infect Control. 2000, 28: 109-115. 10.1016/S0196-6553(00)90018-X.View ArticlePubMedGoogle Scholar
- Fry DE: The economic costs of surgical site infection. Surg Infect (Larchmt). 2002, 3 (Suppl 1): S37-S43.View ArticleGoogle Scholar
- de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB: Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009, 37: 387-397. 10.1016/j.ajic.2008.12.010.View ArticlePubMedGoogle Scholar
- Broex ECJ, van Asselt ADI, Bruggeman CA, van Tiel FH: Surgical site infections: how high are the costs?. J Hosp Infect. 2009, 72: 193-201. 10.1016/j.jhin.2009.03.020.View ArticlePubMedGoogle Scholar
- KISS: Surveillance System postoperative Wundinfektionen. http://www.nrz-hygiene.de/surveillance/kiss/]
- Reid K, Pockney P, Draganic B, Smith SR: Barrier wound protection decreases surgical site infection in open elective colorectal surgery: a randomized clinical trial. Dis Colon Rectum. 2010, 53: 1374-1380. 10.1007/DCR.0b013e3181ed3f7e.View ArticlePubMedGoogle Scholar
- Horiuchi T, Tanishima H, Tamagawa K, Matsuura I, Nakai H, Shouno Y, Tsubakihara H, Inoue M, Tabuse K: Randomized, controlled investigation of the anti-infective properties of the Alexis retractor/protector of incision sites. J Trauma. 2007, 62: 212-215. 10.1097/01.ta.0000196704.78785.ae.View ArticlePubMedGoogle Scholar
- Sookhai S, Redmond HP, Deasy JM: Impervious wound-edge protector to reduce postoperative wound infection: a randomised, controlled trial. Lancet. 1999, 353: 1585.View ArticlePubMedGoogle Scholar
- Kato Y, Marusasa T, Ichikawa S, Lane GJ, Okazaki T, Yamataka A: Lapprotector use decreases incisional wound infections in cases of perforated appendicitis: a prospective study. Asian J Surg. 2008, 31: 101-103. 10.1016/S1015-9584(08)60068-8.View ArticlePubMedGoogle Scholar
- Psaila JV, Wheeler MH, Crosby DL: The role of plastic wound drapes in the prevention of wound infection following abdominal surgery. Br J Surg. 1977, 64: 729-732. 10.1002/bjs.1800641012.View ArticlePubMedGoogle Scholar
- Kercher KW, Nguyen TH, Harold KL, Poplin ME, Matthews BD, Sing RF, Heniford BT: Plastic wound protectors do not affect wound infection rates following laparoscopic-assisted colectomy. Surg Endosc. 2004, 18: 148-151. 10.1007/s00464-003-8137-6.View ArticlePubMedGoogle Scholar
- Nyström PO, Broomé A, Höjer H, Ling L: A controlled trial of a plastic wound ring drape to prevent contamination and infection in colorectal surgery. Dis Colon Rectum. 1984, 27: 451-453. 10.1007/BF02555535.View ArticlePubMedGoogle Scholar
- Anthony T, Murray BW, Sum-Ping JT, Lenkovsky F, Vornik VD, Parker BJ, McFarlin JE, Hartless K, Huerta S: Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg. 2011, 146: 263-269. 10.1001/archsurg.2010.249.View ArticlePubMedGoogle Scholar
- Fairclough JA, Johnson D, Mackie I: The prevention of wound contamination by skin organisms by the pre-operative application of an iodophor impregnated plastic adhesive drape. J Int Med Res. 1986, 14: 105-109.PubMedGoogle Scholar
- Yoshimura Y, Kubo S, Hirohashi K, Ogawa M, Morimoto K, Shirata K, Kinoshita H: Plastic iodophor drape during liver surgery operative use of the iodophor-impregnated adhesive drape to prevent wound infection during high risk surgery. World J Surg. 2003, 27: 685-688. 10.1007/s00268-003-6957-0.View ArticlePubMedGoogle Scholar
- Chiu KY, Lau SK, Fung B, Ng KH, Chow SP: Plastic adhesive drapes and wound infection after hip fracture surgery. Aust N Z J Surg. 1993, 63: 798-801. 10.1111/j.1445-2197.1993.tb00343.x.View ArticlePubMedGoogle Scholar
- Dewan PA, Van Rij AM, Robinson RG, Skeggs GB, Fergus M: The use of an iodophor-impregnated plastic incise drape in abdominal surgery-a controlled clinical trial. Aust N Z J Surg. 1987, 57: 859-863. 10.1111/j.1445-2197.1987.tb01281.x.View ArticlePubMedGoogle Scholar
- Webster J, Alghamdi A: Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane Database Syst Rev. 2007, 4: CD006353.PubMedGoogle Scholar
- Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R: Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973, 60: 646-649. 10.1002/bjs.1800600817.View ArticlePubMedGoogle Scholar
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH E6. Harmonised Guideline for Good Clinical Practice. 1996, Geneva, Switzerland: ICHGoogle Scholar
- Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P: CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003, 13: 176-181. 10.1016/S1053-4296(03)00031-6.View ArticlePubMedGoogle Scholar
- Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS: Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991, 91: 152-157. 10.1016/0002-9343(91)90361-Z.View ArticleGoogle Scholar
- van Buuren S: Multiple imputation of discrete and continuous data by fully conditional specification. Stat Methods Med Res. 2007, 16: 219-242. 10.1177/0962280206074463.View ArticlePubMedGoogle Scholar
- O’Brien PC, Fleming TR: A multiple testing procedure for clinical trials. Biometrics. 1979, 35: 549-556. 10.2307/2530245.View ArticlePubMedGoogle Scholar
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH E9. Statistical Principles for Clinical Trials. 1998, Geneva, Switzerland: ICHGoogle Scholar
- World Medical Association: Declaration of Helsinki - Ethical principles for medical research involving human subjects. Proceedings of the 59th WMA General Assembly, Seoul, Korea, October 2008Google Scholar
- Alexander JW, Solomkin JS, Edwards MJ: Updated recommendations for control of surgical site infections. Ann Surg. 2011, 253: 1082-1093. 10.1097/SLA.0b013e31821175f8.View ArticlePubMedGoogle Scholar
- Melling AC, Ali B, Scott EM, Leaper DJ: Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial. Lancet. 2001, 358: 876-880. 10.1016/S0140-6736(01)06071-8.View ArticlePubMedGoogle Scholar
- Kurz A, Sessler DI, Lenhardt R: Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996, 334: 1209-1215. 10.1056/NEJM199605093341901.View ArticlePubMedGoogle Scholar
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