NCT07003906

Brief Summary

The goal of this clinical trial is to investigate Negative Pressure Wound Therapy (NPWT) in adults undergoing emergency laparotomy. The main question it aims to answer is: Does NPWT decrease wound complications? Researchers will compare it against regular dressings to see if NPWT is superior.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
115mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
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 Progress5%
Dec 2025Dec 2035

First Submitted

Initial submission to the registry

May 14, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

December 16, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

May 14, 2025

Last Update Submit

December 18, 2025

Conditions

Surgical IncisionWound DehiscenceSurgical Site InfectionIncisional HerniaQuality of Life

Keywords

emergency surgerynegative pressure wound therapyrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Wound complications

    Incident rate of wound complications (infection, dehiscence, seroma)

    7 and 30 days

Secondary Outcomes (19)

  • Surgical site infections

    7 and 30 days

  • Wound dehiscence

    7 and 30 days

  • Length of stay

    30 days

  • Quality of life survey

    30 days and 1 year

  • Scar satisfaction

    30 days and 1 year

  • +14 more secondary outcomes

Study Arms (2)

Investigational device

EXPERIMENTAL

Will recieve 7 days of treatment with negative pressure wound therapy after closure of emergency surgery incision

Device: Negative pressure wound therapy

Standard of care

ACTIVE COMPARATOR

Will recieve a regular dressing after closure of emergency surgery incision

Device: Standard postoperative dressing

Interventions

Negative pressure wound therapyDEVICE

Avance Solo Negative Pressure Wound Therapy (NPWT) System is a portable battery powered single use negative pressure system, suitable for use in closed incision and chronic wound indications. The system consists of Avance Solo Pump, Avance Solo Canister 50 mL, Avance Solo Border Dressing and Avance Solo Foam.

Also known as: Avance Solo
Investigational device
Standard postoperative dressingDEVICE

Mepilex Border Post-Op is a self-adhesive absorbent surgical dressing designed for exuding wounds. It is intended for acute wounds, such as surgical wounds, cuts and abrasions.

Also known as: Mepilex Border Post-Op
Standard of care

Eligibility Criteria

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

You may qualify if:

  • ≥18 years old
  • Written informed consent
  • \>10 cm midline incision with primary skin closure
  • Emergency laparotomy

You may not qualify if:

  • Not able to consent (e.g. dementia, impaired cognitive function, unconscious)
  • Subjects not possible to follow up as assessed by the Investigator
  • Allergy to dressing material
  • Pregnancy or breastfeeding (females of childbearing potential)
  • Previous enrolment in the current study
  • Expected reoperation with 28 days of index laparotomy
  • Emergency laparotomy within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Mälar Hospital

Eskilstuna, Sweden

NOT YET RECRUITING

Linköping University Hospital

Linköping, Sweden

NOT YET RECRUITING

Mora Hospital

Mora, Sweden

NOT YET RECRUITING

Vrinnevi Hospital

Norrköping, Sweden

NOT YET RECRUITING

Uppsala University Hospital

Uppsala, 75185, Sweden

RECRUITING

Västmanlands Hospital Västerås

Västerås, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Surgical WoundSurgical Wound InfectionIncisional Hernia

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wounds and InjuriesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsHerniaPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Central Study Contacts

Erik Osterman, MD PhD

CONTACT

+460186110000erik.osterman@akademiska.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Assessments and analyses will be masked. It's not feasible to blind Participants and Care Providers
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2025

First Posted

June 4, 2025

Study Start

December 16, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2035

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations

SE(6)