Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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
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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