Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07003906

Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy

Led by Uppsala University · Updated on 2025-12-26

720

Participants Needed

6

Research Sites

365 weeks

Total Duration

On this page

Sponsors

U

Uppsala University

Lead Sponsor

U

Uppsala County Council, Sweden

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating Negative Pressure Wound Therapy (NPWT) in adults undergoing emergency laparotomy to see if it reduces wound complications compared to regular dressings. The study focuses on wound issues such as surgical site infections, wound dehiscence, and seromas following urgent abdominal surgery. This investigation is sponsored by Uppsala University and aims to determine if NPWT dressings can lower these complication rates and improve patient outcomes. Participants will be randomly assigned at the time of skin closure to receive either NPWT using the Avance Solo system or a standard postoperative dressing called Mepilex Border Post-Op. The NPWT system uses suction to clear fluids from the wound, while the standard dressing is absorbent and self-adhesive. Treatment lasts for 7 days following wound closure. No other aspects of care will be changed between groups. During the study, participants will be followed up at 7, 30, and 365 days after surgery. Follow-up includes visits, surveys on quality of life and scar satisfaction, and an optional CT scan to check for incisional hernia formation. Researchers will monitor wound complications, infection rates, length of hospital stay, need for antibiotics, reoperation rates, and other health outcomes over short and long-term periods, up to 5 years. This comprehensive monitoring will help assess the overall impact of NPWT on recovery and wound healing.

CONDITIONS

Brief Title

Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Able to provide written informed consent
  • Midline incision longer than 10 cm with primary skin closure
  • Undergoing emergency laparotomy surgery
Not Eligible

You will not qualify if you...

  • Unable to give consent due to cognitive impairment or unconsciousness
  • Cannot be followed up as judged by the investigator
  • Allergy to dressing materials used in the study
  • Pregnant or breastfeeding (for females of childbearing potential)
  • Previously enrolled in this study
  • Expected to need reoperation within 28 days of surgery
  • Emergency laparotomy performed within the last 3 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) before surgery for eligibility and consent

Surgery and Immediate Post-operative Care

Duration - 7 days

Participants undergo emergency laparotomy surgery and receive either negative pressure wound therapy dressings or standard postoperative dressings applied at the time of skin closure.

Treatment applied continuously for 7 days post-surgery

Post-operative Follow-up

Duration - Up to 1 year

Participants are followed up to monitor wound complications and other outcomes after surgery.

Visits at 7 days, 30 days, and 1 year; surveys and optional CT scan offered at 1 year

Trial Site Locations

Total: 6 locations

1

Mälar Hospital

Eskilstuna, Sweden

Not Yet Recruiting

2

Linköping University Hospital

Linköping, Sweden

Not Yet Recruiting

3

Mora Hospital

Mora, Sweden

Not Yet Recruiting

4

Vrinnevi Hospital

Norrköping, Sweden

Not Yet Recruiting

5

Uppsala University Hospital

Uppsala, Sweden, 75185

Actively Recruiting

6

Västmanlands Hospital Västerås

Västerås, Sweden

Not Yet Recruiting

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Research Team

E

Erik Osterman, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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