Abstract
BackgroundPostoperative 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.Methods/designTo 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.DiscussionThe 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.Trial registrationhttp://www.clinicaltrials.gov NCT01181206. Date of registration: 11 August 2010; date of first patient randomized: 8 September 2010
Highlights
Postoperative surgical site infections cause substantial morbidity, prolonged hospitalization, costs and even mortality and remain one of the most frequent surgical complications
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
Previous trials Several previous trials have investigated the effect of wound edge protectors on SSI rates in abdominal surgery and report mixed results
Summary
Postoperative SSIs are among the most frequent surgical complications affecting approximately 14% to 32% [14,15,16,17] of abdominal surgical patients. In abdominal surgical patients E. coli, Enterococcus spp, Enterobacter spp and S. aureus are the most frequent pathogens (KISS data 2005 to 2008, [29]) These data indicate that endogenous infections from the patientsskin 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 prevent displacement of skin pathogens into the surgical site such as. 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
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