NCT05684198

Brief Summary

The study aims to evaluate the efficacy of negative pressure wound therapy (NPWT) compared with primary closure (PC) in surgical site infection (SSI) prevention for laparotomy for peritonitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

December 3, 2025

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

November 29, 2022

Last Update Submit

November 25, 2025

Conditions

PeritonitisSurgical Site InfectionInfectionsWound Infection

Keywords

laparotomyNPWTprimary closurevacuum-assisted closureVAC

Outcome Measures

Primary Outcomes (2)

  • Effective wound closure by 30th day post-op

    definitive wound closure, not followed by secondary wound dehiscence

    30 days

  • Time to end of surgical treatment of the wound

    Time of last out-patient visit ending the process of treating surgical wound

    1 year

Secondary Outcomes (9)

  • Length of stay

    90 days

  • Time to heal

    120 days

  • Volume of wound drainage

    60 days

  • Time of secondary NPWT treatment

    60 days

  • Post-operative morbidity

    60 days

  • +4 more secondary outcomes

Study Arms (2)

subcutaneous NPWT

EXPERIMENTAL

The peritoneum and fascia will be closed as in the PC arm. Subsequently, patients will be treated with commercially available vacuum-assisted closure systems (provided by Smith\&Nephew or Hartmann) according to the manufacturer's instructions. Following fascia closure, the NPWT foam will be adjusted to the wound size to fill the wound cavity without causing excessive wound dehiscence. Subsequently, the foam will be placed in the subcutaneous tissue. The foam will not be fixated on the skin with sutures. The wound will be sealed with adhesive film. In case of air leak in problematic areas such as the navel or ostomy, ostomy paste will be used to create a tighter seal. Continuous pressure of 120 mmHg will be applied. On the 3rd day postop, the dressing will be removed and closure by secondary intention will be performed.

Device: subcutaneous NPWT

primary closure

NO INTERVENTION

The peritoneum will be closed as a separate layer with a 2-0 multifilament absorbable suture. Subsequently, the fascia will be closed with a continuous suture using absorbable monofilament 0 sutures. Subcutaneous tissue will be rinsed twice with hypochlorite solution following peritoneal closure and fascial closure. Interrupted subcutaneous closure will be performed with absorbable multifilament 2-0 sutures. Following skin disinfection with an alcohol solution, the skin will be closed with non-absorbable monofilament 2-0 or 3-0 sutures using the interrupted mattress technique. Conventional Cosmopor® sterile gauze dressings will be applied. Unless the dressing material will be saturated, the dressing will remain unchanged until 3rd day post-op.

Interventions

subcutaneous NPWTDEVICE

Following fascia closure, NPWT system will be inserted into subcutaneous tissue, continuous negative pressure of 120 mmHg will be applied.

Also known as: vacuum-assisted wound closure, Vivano, Renasys
subcutaneous NPWT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • qualified for an emergency laparotomy for peritonitis
  • gave written informed consent

You may not qualify if:

  • qualified for open abdomen treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCC Division of Oncological, Transplant and General Surgery

Gdansk, Pomeranian Voivodeship, 80952, Poland

Location

MeSH Terms

Conditions

PeritonitisSurgical Wound InfectionInfectionsWound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsPeritoneal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • Piotr Spychalski, MD PhD

    MUG Division of General Surgery

    PRINCIPAL INVESTIGATOR

  • Katarzyna M Polomska

    Medical University of Gdansk (MUG)

    PRINCIPAL INVESTIGATOR

  • Jaroslaw Kobiela, Prof.

    MUG Division of General Surgery

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 29, 2022

First Posted

January 13, 2023

Study Start

January 11, 2023

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

December 3, 2025

Record last verified: 2023-05

Locations

PL(1)