NCT06068517

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
654

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026May 2028

First Submitted

Initial submission to the registry

September 27, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
2.4 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

September 27, 2023

Last Update Submit

December 4, 2024

Conditions

Surgical Wound Infection

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 (+/- 7) days

Secondary Outcomes (10)

  • Overall surgical site infections (superficial, deep, and organ space)

    30 (+/- 7) days

  • Superficial, deep, and organ space surgical site infections as separate outcomes

    30 (+/- 7) days

  • Other wound complications (wound dehiscence, seroma, hematoma)

    30 (+/- 7) days

  • Postoperative hospital length of stay

    Usually between 1 and 14 days

  • Duration of closed incision negative pressure wound therapy

    7 days

  • +5 more secondary outcomes

Study Arms (2)

Closed incision negative pressure wound therapy

EXPERIMENTAL

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.

Device: Closed incision negative pressure wound therapy

Standard dressing

ACTIVE COMPARATOR

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.

Device: Standard dressing

Interventions

Closed incision negative pressure wound therapyDEVICE

After the completion of abdominal surgery and standardised skin closure with staples, ciNPWT will be applied, using a commercially available device.

Closed incision negative pressure wound therapy
Standard dressingDEVICE

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

Standard dressing

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tobias Haltmeier, MD

    Inselspital, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Haltmeier, MD

CONTACT

31 664 03 04tobias.haltmeier@insel.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 5, 2023

Study Start

March 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

May 31, 2028

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)