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

André L Mihaljevic, Christoph W Michalski, Mert Erkan, Carolin Reiser-Erkan, Carsten Jäger, Tibor Schuster, Christoph Schuhmacher, Jörg Kleeff, Helmut Friess, André L Mihaljevic, Christoph W Michalski, Mert Erkan, Carolin Reiser-Erkan, Carsten Jäger, Tibor Schuster, Christoph Schuhmacher, Jörg Kleeff, Helmut Friess

Abstract

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov NCT01181206.

Figures

Figure 1
Figure 1
Schematic drawing of the wound edge protectors used in the BaFO trial. The protector consists of an impervious drape that covers the abdomen of the patient and is fixed to the skin with the help of adhesive tapes. It has a standardized size of 90 × 90 cm. The hole in the middle is connected to a flexible plastic ring that fits into the abdominal wound and protects the wound edges (skin, subcutaneous tissue, fascia and muscle) from contact with viscera, visceral contents and gloves, while allowing for visualization of the wound edges.
Figure 2
Figure 2
Flow chart of the BaFO trial. F/U = follow-up; postop day = postoperative day; R = randomization; SSI = surgical site infection.

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Source: PubMed

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