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

Not Applicable

Not yet recruiting

• Conditions: Surgical Wound Infection

• Registration Number: NCT06068517
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Study Start: 2026-03-01
• Primary Completion: 2027-10-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 654

Inclusion Criteria

• 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
• Primary abdominal closure or closure after open abdomen treatment
• Age over 18 years
• Written informed consent

Exclusion Criteria

• Age ≤ 18 years
• CDC wound class 4 (dirty/infected wound)
• Organ transplantation
• Sensitivity or allergy to silver

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite incidence of superficial and deep surgical site infections	30 (+/- 7) days	Number of participants with a superficial or deep surgical site infections at 30 (+/- 7) days postoperatively.

Secondary Outcome Measures

Name	Time	Method
Duration of closed incision negative pressure wound therapy	7 days
Overall surgical site infections (superficial, deep, and organ space)	30 (+/- 7) days	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	30 (+/- 7) days	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)	30 (+/- 7) days	Number of participants with another wound complication at 30 (+/- 7) days postoperatively.
Number of outpatient visits	30 days
Costs for inpatient treatment	Usually between 1 and 14 days
In-hospital mortality	Usually between 1 and 14 days
Postoperative health-related quality of life (SF-36 Health Survey)	30 (+/- 7) days	Range from 0 (worst) to 100 (best).
30-day mortality	30 days
Postoperative hospital length of stay	Usually between 1 and 14 days

Trial Locations

Locations (1)

Inselspital, Bern University Hospital; 🇨🇭 Bern, Switzerland