Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-16

Study Completion Date

2035-12-31

Brief Summary

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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.

Detailed Description

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Negative Pressure Wound Therapy (NPWT) is a method of treating wounds using suction. The dressing is airtight, and the pump creates subatmospheric pressure, clearing the wound of exudate and fluids.

The study aims to investigate the effect of Negative pressure wound therapy dressings on the rate of wound complications (SSI, WD, seroma) after emergency laparotomy. Patients will be randomised to regular dressings and investigational device 1:1. No other aspect of the care will be changed.

Randomisation is planned at the time of skin closure. Patients will be followed-up after 7, 30 and 365 days with two initial visits, surveys and offered a CT scan to investigate incisional hernia formation.

The hypothesis is that NPWT dressings decrease the rate of wound complications. The secondary outcome is reduction of SSI, WD, seroma, shorter length of stay, peri-wound blistering, patient satisfaction.

Conditions

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Surgical Incision Wound Dehiscence Surgical Site Infection Incisional Hernia Quality of Life

Keywords

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emergency surgery negative pressure wound therapy randomised controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Assessments and analyses will be masked. It's not feasible to blind Participants and Care Providers

Study Groups

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Investigational device

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

Group Type EXPERIMENTAL

Negative pressure wound therapy

Intervention Type DEVICE

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.

Standard of care

Will recieve a regular dressing after closure of emergency surgery incision

Group Type ACTIVE_COMPARATOR

Standard postoperative dressing

Intervention Type DEVICE

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.

Interventions

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Negative pressure wound therapy

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.

Intervention Type DEVICE

Standard postoperative dressing

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.

Intervention Type DEVICE

Other Intervention Names

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Avance Solo Mepilex Border Post-Op

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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