Surgical site infections (SSI) are a frequent complication in abdominal surgery. SSI lead to worse outcomes for the affected patients and significantly higher healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) consists of a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. It is currently unclear, if ciNPWT reduces SSI in patients undergoing abdominal surgery. This trial will investigate the effect of ciNPWT on SSI in abdominal surgery.
Elective or emergency laparotomy, or laparoscopy converted to laparotomy, including surgery for complications after elective operations
Incision length ≥ 10 cm
Centers for Disease Control and Prevention (CDC) wound class 1 and 2 (clean, clean-contaminated)
Abdominal closure with or without mesh implantation
Age ≤ 18 years
CDC wound class 4 (dirty/infected wound)
Organ transplantation
Sensitivity or allergy to silver
Parallel
Closed incision negative pressure wound therapy
DeviceAfter the completion of abdominal surgery and standardised skin closure with staples, ciNPWT will be applied, using a commercially available device.
Standard dressing
DeviceAfter the completion of abdominal surgery and standardised skin closure with staples, standard dressings will be applied.
Composite incidence of superficial and deep surgical site infections
Number of participants with a superficial or deep surgical site infections at 30 (+/- 7) days postoperatively.
Overall surgical site infections (superficial, deep, and organ space)
Number of participants with a superficial or deep or organ space surgical site infections at 30 (+/- 7) days postoperatively.
Superficial, deep, and organ space surgical site infections as separate outcomes
Number of participants with a superficial surgical site infections at 30 (+/- 7) days postoperatively. Number of participants with a deep surgical site infections at 30 (+/- 7) days postoperatively. Number of participants with an organ space surgical site infections at 30 (+/- 7) days postoperatively.
Other wound complications (wound dehiscence, seroma, hematoma)
Number of participants with another wound complication at 30 (+/- 7) days postoperatively.
Postoperative hospital length of stay
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Insel Gruppe AG, University Hospital Bern
Lead sponsor
Clinical Trials Unit University of Bern
Collaborator
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