Abstract
BackgroundPostoperative surgical site infections cause substantial morbidity, prolonged hospitalization, costs and even mortality, and remain one of the most frequent surgical complications. In prospective trials with adequate follow-up, more than 20 % of patients undergoing elective colorectal surgery are affected and methods to reduce surgical site infections are urgently needed. Negative-pressure incision therapy is a novel intervention that holds promise to reduce postoperative wound infection rates, but has not yet been rigorously tested in a randomized controlled trial.Methods/DesignThe aim is to investigate whether the postoperative application of a negative-pressure incision therapy device for 5–7 days reduces the rate of surgical site infections following open elective colorectal surgery by 50 %. This is a randomized, controlled, observer-blinded multicentre clinical trial with two parallel study groups. The primary outcome measure will be the rate of surgical site infections within 30 days postoperatively. Surgical site infections are defined according to criteria of the US Centers for Disease Control and Prevention. Statistical analysis of the primary endpoint measure will be based on the intention-to-treat population. The global level of significance is set at 5 % (two-sided) and the sample size (n = 170 per group) is determined to assure a power of 80 %.DiscussionThe Poniy trial will explore whether the rate of surgical site infections can be reduced by the application of a negative-pressure incision therapy device in patients undergoing open elective colorectal surgery. Its pragmatic design guarantees high external validity and clinical relevance.Trial registrationDeutsches Register Klinischer Studien DRKS00006199.
Highlights
Postoperative surgical site infections cause substantial morbidity, prolonged hospitalization, costs and even mortality, and remain one of the most frequent surgical complications
The Poniy trial will explore whether the rate of surgical site infections can be reduced by the application of a negative-pressure incision therapy device in patients undergoing open elective colorectal surgery
Despite the implementation of such preventive measures as preoperative antibiotic prophylaxis [9,10,11] and antiseptic skin cleansing [9, 12], surgical site infection rates in prospective trials using the standardized criteria of the US Centers for Disease Control and Prevention (CDC) remain above 15 % after general abdominal surgery [13,14,15,16]
Summary
Postoperative surgical site infections are amongst the most frequent surgical complications, affecting approximately 14 % to 32 % of patients undergoing abdominal surgery [18, 42, 43]. In abdominal surgical patients, E. coli, Enterococcus species, Enterobacter species and S. aureus are the most frequently pathogens isolated from wounds [7] These data indicate that endogenous contaminations from the patients’ skin or the gastrointestinal tract occurring during surgery account for most surgical site infections. The Poniy trial was designed to test the efficacy of NPIT in comparison with standard sterile dressings in a group at high risk of surgical site infection, i.e., patients undergoing open colorectal surgery. All authors read and approved the final version of the manuscript
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