Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery
NCT ID: NCT06068517
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
654 participants
INTERVENTIONAL
2026-03-01
2028-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Closed incision negative pressure wound therapy
At the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, ciNPWT will be applied, using a commercially available device. The device will be left in place for 7 days.
Closed incision negative pressure wound therapy
After the completion of abdominal surgery and standardised skin closure with staples, ciNPWT will be applied, using a commercially available device.
Standard dressing
At the completion of the surgical procedure, the skin will be closed with staples at a distance of two centimeters from each other. After skin closure, conventional dry dressings will be applied. Conventional dressings will be changed according to clinical practice in the participating study centers.
Standard dressing
After the completion of abdominal surgery and standardised skin closure with staples, standard dressings will be applied.
Interventions
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Closed incision negative pressure wound therapy
After the completion of abdominal surgery and standardised skin closure with staples, ciNPWT will be applied, using a commercially available device.
Standard dressing
After the completion of abdominal surgery and standardised skin closure with staples, standard dressings will be applied.
Eligibility Criteria
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Inclusion Criteria
* 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
* CDC wound class 4 (dirty/infected wound)
* Organ transplantation
* Sensitivity or allergy to silver
19 Years
ALL
Yes
Sponsors
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Clinical Trials Unit University of Bern
UNKNOWN
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Tobias Haltmeier, MD
Role: PRINCIPAL_INVESTIGATOR
Inselspital, Bern University Hospital
Locations
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Inselspital, Bern University Hospital
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Tobias Haltmeier, MD
Role: primary
Other Identifiers
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CISSI
Identifier Type: -
Identifier Source: org_study_id