%0 Journal Article
%T 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
%A Andre L Mihaljevic
%A Christoph W Michalski
%A Mert Erkan
%A Carolin Reiser-Erkan
%A Carsten Jaeger
%A Tibor Schuster
%A Christoph Schuhmacher
%A J£¿rg Kleeff
%A Helmut Friess
%J Trials
%D 2012
%I BioMed Central
%R 10.1186/1745-6215-13-57
%X 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 webcite NCT01181206. Date of registration: 11 August 2010; date of first patient randomized: 8 September 2010
%K Abdominal dressing
%K Abdominal surgery
%K Randomized trial
%K Surgical site infection
%K Wound edge protector
%K Wound infection
%U http://www.trialsjournal.com/content/13/1/57/abstract