Clinical trial NCT07003906: Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy
Official title: Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgical Incision
Wound Dehiscence
Surgical Site Infection
Incisional Hernia
Quality of Life
Keywords: emergency surgery
negative pressure wound therapy
randomised controlled trial
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala County Council, Sweden
name: Dalarna County Council, Sweden
name: Sormland County Council, Sweden
name: Ostergotland County Council, Sweden
name: Västmanland County Council, Sweden
name: Landstingens Ömsesidiga Försäkringsbolag (Löf)
First posted: 2025-06-04
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wound complications
timeFrame: 7 and 30 days
Secondary outcomes:
measure: Surgical site infections
timeFrame: 7 and 30 days
measure: Wound dehiscence
timeFrame: 7 and 30 days
measure: Length of stay
timeFrame: 30 days
measure: Quality of life survey
timeFrame: 30 days and 1 year
measure: Scar satisfaction
timeFrame: 30 days and 1 year
measure: Incidence of incisional hernias
timeFrame: 1 year
measure: Mortality
timeFrame: 7, 30 days and 1 year
measure: Costs
timeFrame: 30 days
measure: Incidence of hernias
timeFrame: 5 years
measure: Incidence of small bowel obstruction
timeFrame: 5 years
measure: Incidence of reconstructive surgery
timeFrame: 5 years
measure: Incidence rate of seromas
timeFrame: 7 and 30 days
measure: Incidence of hematomas
timeFrame: 7 and 30 days
measure: Incidence of ischemia around and in wound
timeFrame: 7 and 30 days
measure: Incidence of enterocutaneus fistula
timeFrame: 7 and 30 days
measure: Need for antibiotics after surgery
timeFrame: 7 and 30 days
measure: Incidence of other infections after surgery
timeFrame: 7 and 30 days
measure: Number of healthcare visits after surgery
timeFrame: 7 and 30 days
measure: Reoperation rate
timeFrame: 7 and 30 days
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Mälar Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Mora
country: Sweden
facility: Mora Hospital
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Västerås
country: Sweden
facility: Västmanlands Hospital Västerås
Study officials:
References: