Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07003906
• Lead Sponsor: Uppsala University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-26
• Status Verified: 2025-06
• Study First Posted: 2025-06-04
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-10
• Study Start: 2025-09
• Primary Completion: 2028-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 720

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wound complications	7 and 30 days	Incident rate of wound complications (infection, dehiscence, seroma)

Secondary Outcome Measures

Name	Time	Method
Length of stay	30 days
Quality of life survey	30 days and 1 year	EuroQoL Scale with 5 dimensions and 5 levels (EQ5D-5L). Patients scores in each dimension and total score indexed score is calculated where higher is better quality of life. Scores are weighted using published population values where 1 equals full health and worse health states goes towards, but can not reach 0. The EQ5D-5L also includes a VAS scale 0-100 where 100 is the best imaginable health and 0 the worst.
Scar satisfaction	30 days and 1 year	Patient and Observer Scar Assessment Scale (POSAS 2.0). Includes pain, vascularity, pigmentation, thickness, relief, pliability and surface area. Lower total score is better. The scale goes from 6-60 for patients and 6-60 for observers. Both also estimate an overall score 1-10 which is not included in the total score when using that aspect of the POSAS.
Mortality	7, 30 days and 1 year
Costs	30 days	Cost of dressing and health care
Incidence of hernias	5 years	Hernia surgery and diagnoses from the National Patient Registry.
Incidence of small bowel obstruction	5 years	Small bowel obstruction surgery and diagnoses from the National Patient Registry.
Incidence of reconstructive surgery	5 years	Reconstructive abdominal wall surgery from the National Patient Registry.
Incidence rate of seromas	7 and 30 days	Seroma, i.e. collection of fluid in the subcutaneous tissue.
Incidence of hematomas	7 and 30 days	Hematoma, a collection of blood in the subcutaneous tissues.
Incidence of ischemia around and in wound	7 and 30 days	Composite measure of ischemia, necrosisis in wound
Incidence of enterocutaneus fistula	7 and 30 days	Enterocutaneous fistula formation
Need for antibiotics after surgery	7 and 30 days	Incidence rate of antibiotic treatment
Incidence of other infections after surgery	7 and 30 days	Composite measure of other infections (e.g., deep abdominal infections, urinary tract infections, pneumonia)
Number of healthcare visits after surgery	7 and 30 days	Number of healthcare visits
Reoperation rate	7 and 30 days	Any unscheduled surgery after first surgery
Surgical site infections	7 and 30 days
Wound dehiscence	7 and 30 days	Rupture of skin or fascia assessed clinically or with radiology.
Incidence of incisional hernias	1 year	The incidence rate of incisional hernia, the measure is assessed by computer tomography, the need for surgery and clinical diagnosis

Trial Locations

Locations (6)

Mälar Hospital; 🇸🇪 Eskilstuna, Sweden

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Mora Hospital; 🇸🇪 Mora, Sweden

Vrinnevi Hospital; 🇸🇪 Norrköping, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Västmanlands Hospital Västerås; 🇸🇪 Västerås, Sweden