Abstract
Background: Surgical site infection (SSI) after abdominal surgery is still a significant morbidity associated with an increased socioeconomic burden and poor quality of life. SSI prevalence rates as high as 40% in cases of fecal contamination have been reported; however, current methods to reduce SSI are limited to elective abdominal surgery. Further evaluation of preventive measures for reducing SSI is necessary.
Methods/design: The COVER trial investigates whether the application of a dual-ring circular plastic wound protector reduces the rate of SSI in patients undergoing open abdominal surgery related to the gastrointestinal (GI) tract, regardless of the type of wound classified by the Center for Disease Control (CDC). The COVER trial is a multicenter, randomized controlled clinical trial with two parallel arms – one using a wound protector and the other using conventional surgical dressing gauze. The primary outcome will measure the rate of SSI in two groups. Statistical analysis of the primary end point will be based on the intention-to-treat population. The sample size is determined to achieve a study power of 80% at 95% 2-sided confidence limits. Considering a dropout rate of up to 5%, a total of 458 patients, 229 patients in each group, will be enrolled in this study.
Discussion: The COVER trial will provide high-quality evidence for using a circular polyethylene drape in open abdominal surgery for the GI tract in all types of wound. The design of the trial will deliver high external validity and clinical significance.
Trial registration: The trial protocol was registered at ClinicalTrials.gov (NCT 03170843) on May 31, 2017. https://clinicaltrials.gov/ct2/show/NCT03170843?term=NCT+03170843&rank=1
Keywords: Circular polyethylene drape, Abdominal surgery, Gastrointestinal tract, Surgical site infection, Randomized controlled trial
Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery
