Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery

Background:

Surgical site infections (SSI) are a frequent complication after abdominal surgery and are associated with increased morbidity and mortality, longer hospital stay, and significantly increased healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) is a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. Recent meta-analyses suggest that ciNPWT reduces the risk of SSI in abdominal surgery. However, based on the available randomized controlled trials (RCT), the evidence for the effect of ciNPWT on SSI in abdominal surgery is insufficient.

Rationale:

Considering the frequent occurrence of SSI in abdominal surgery, associated worse outcomes, and insufficient evidence, an adequately powered, robust RCT investigating the effect of ciNPWT on SSI in elective and emergency abdominal surgery is warranted. Provided that ciNPWT significantly reduces the incidence of SSI, this adjunct to surgical therapy has the potential to fundamentally improve patient outcomes in abdominal surgery.

Aim of the trial:

To investigate the effect of ciNPWT on superficial and deep SSI in patients undergoing elective or emergency abdominal surgery by laparotomy.

Methodology:

Multicenter, open-label, two arm, parallel group RCT. Patients undergoing elective or emergency laparotomy will be enrolled. During surgery, participants will be randomized in a 1:1 ratio to the ciNPWT (treatment) or standard dressing (control) group. After the completion of abdominal surgery and standardized skin closure with staples, either ciNPWT or standard dry dressings will be applied. Other than the study procedure, participants in both groups will be treated the same according to the current standard of care at the participating centers. Data collection will be carried out during the subsequent hospital stay and at 30 (+/- 7) days postoperatively.

Hypothesis:

The investigators hypothesize that ciNPWT will significantly reduce the incidence of superficial and deep SSI in patients undergoing laparotomy.

• Overall surgical site infections (superficial, deep, and organ space) [Срок оценки: 30 (+/- 7) days]
• Superficial, deep, and organ space surgical site infections as separate outcomes [Срок оценки: 30 (+/- 7) days]
• Other wound complications (wound dehiscence, seroma, hematoma) [Срок оценки: 30 (+/- 7) days]
• Postoperative hospital length of stay [Срок оценки: Usually between 1 and 14 days]
• Duration of closed incision negative pressure wound therapy [Срок оценки: 7 days]
• Number of outpatient visits [Срок оценки: 30 days]
• Postoperative health-related quality of life (SF-36 Health Survey) [Срок оценки: 30 (+/- 7) days]
• Costs for inpatient treatment [Срок оценки: Usually between 1 and 14 days]
• In-hospital mortality [Срок оценки: Usually between 1 and 14 days]
• 30-day mortality [Срок оценки: 30 days]