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

NCT06068517 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 654

Last updated 2024-12-05

No results posted yet for this study

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.

Conditions

  • Surgical Wound Infection

Interventions

DEVICE

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.

DEVICE

Standard dressing

After the completion of abdominal surgery and standardised skin closure with staples, standard dressings will be applied.

Sponsors & Collaborators

  • Clinical Trials Unit University of Bern

    collaborator UNKNOWN

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Tobias Haltmeier, MD · Inselspital, Bern University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-10-31
Completion
2028-05-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06068517 on ClinicalTrials.gov