Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy (TELIN)

Uppsala University

Status: Enrolling

Conditions: Incisional Hernia; Wound Dehiscence; Quality of Life; Surgical Site Infection; Surgical Incision

Treatments: Device: Negative pressure wound therapy; Device: Standard postoperative dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT07003906

FOU2025-00096 (Other Identifier)

CIV-24-11-049998 (Other Identifier)

TELIN-1337

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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720 participants in 2 patient groups

Investigational device

Experimental group

Description:

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

Treatment:

Device: Negative pressure wound therapy

Standard of care

Active Comparator group

Description:

Will recieve a regular dressing after closure of emergency surgery incision

Treatment:

Device: Standard postoperative dressing