Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Negative pressure wound therapy, Standard postoperative dressing.
- Who it may be relevant to
- Registry conditions: Surgical Incision, Wound Dehiscence, Surgical Site Infection, Incisional Hernia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 14, 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.
Interventions
- Device 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. - 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.
Primary outcome measures
- Wound complications [Time frame: 14 and 30 days]
Secondary outcome measures (12)
- Surgical site infections [Time frame: 14 and 30 days]
- Wound dehiscence [Time frame: 14 and 30 days]
- Length of stay [Time frame: 30 days]
- Quality of life survey [Time frame: 30 days and 1 year]
- Scar satisfaction [Time frame: 30 days and 1 year]
- Incidence of incisional hernias [Time frame: 1 year]
- Mortality [Time frame: 14, 30 days and 1 year]
- Costs [Time frame: 30 days]
- Incidence of hernias [Time frame: 5 years]
- Incidence of small bowel obstruction [Time frame: 5 years]
- Incidence of reconstructive surgery [Time frame: 5 years]
- Incidence rate of seromas [Time frame: 14 and 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Sweden · 6 centers
- Mälar Hospital — Eskilstuna
- Linköping University Hospital — Linköping
- Mora Hospital — Mora
- Vrinnevi Hospital — Norrköping
- Uppsala University Hospital — Uppsala
- Västmanlands Hospital Västerås — Västerås
Identifiers
NCT: NCT07003906 · TELIN-1337 · CIV-24-11-049998 · FOU2025-00096