Clinical trial NCT06068517: Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery
Official title: Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery - A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgical Wound Infection
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Clinical Trials Unit University of Bern
First posted: 2023-10-05
Enrollment: 654
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite incidence of superficial and deep surgical site infections
timeFrame: 30 (+/- 7) days
Secondary outcomes:
measure: Overall surgical site infections (superficial, deep, and organ space)
timeFrame: 30 (+/- 7) days
measure: Superficial, deep, and organ space surgical site infections as separate outcomes
timeFrame: 30 (+/- 7) days
measure: Other wound complications (wound dehiscence, seroma, hematoma)
timeFrame: 30 (+/- 7) days
measure: Postoperative hospital length of stay
timeFrame: Usually between 1 and 14 days
measure: Duration of closed incision negative pressure wound therapy
timeFrame: 7 days
measure: Number of outpatient visits
timeFrame: 30 days
measure: Postoperative health-related quality of life (SF-36 Health Survey)
timeFrame: 30 (+/- 7) days
measure: Costs for inpatient treatment
timeFrame: Usually between 1 and 14 days
measure: In-hospital mortality
timeFrame: Usually between 1 and 14 days
measure: 30-day mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Tobias Haltmeier, MD
role: PRINCIPAL_INVESTIGATOR
References: