Negative pressure dressings after emergency midline laparotomy
Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy
This trial will test whether using negative pressure wound therapy on adults having emergency midline laparotomy lowers wound complications compared with standard dressings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Locations | 6 sites (Eskilstuna and 5 other locations) |
| Trial ID | NCT07003906 on ClinicalTrials.gov |
What this trial studies
Adults undergoing emergency midline laparotomy with a primary skin closure and an incision longer than 10 cm are randomized 1:1 at skin closure to receive either a negative pressure wound therapy dressing or a standard postoperative dressing. No other aspects of perioperative care are changed, and patients are followed at 7, 30, and 365 days with two in-person visits, surveys, and an optional CT scan to check for incisional hernia. The primary outcome is the rate of wound complications (surgical site infection, wound dehiscence, seroma), with secondary outcomes including length of stay, peri-wound blistering, and patient satisfaction. The goal is to determine whether NPWT reduces early and late wound complications after emergency laparotomy.
Who should consider this trial
Good fit: Adults (≥18 years) who can give informed consent, undergo emergency midline laparotomy with primary skin closure and an incision longer than 10 cm, and can attend follow-up visits are eligible.
Not a fit: Patients who are pregnant or breastfeeding, allergic to dressing materials, expected to need reoperation within 28 days, had an emergency laparotomy within the past 3 months, or cannot be followed up are unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, NPWT could reduce surgical site infections, wound breakdown, seroma formation, and possibly lower hernia rates and shorten recovery after emergency laparotomy.
How similar studies have performed: Similar NPWT approaches have shown benefit in some elective and high‑risk abdominal wound studies, but their effectiveness specifically after emergency laparotomy is less well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Eskilstuna and 5 other locations
- Mälar Hospital — Eskilstuna, Sweden (Not_yet_recruiting)
- Linköping University Hospital — Linköping, Sweden (Not_yet_recruiting)
- Mora Hospital — Mora, Sweden (Not_yet_recruiting)
- Vrinnevi Hospital — Norrköping, Sweden (Not_yet_recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
- Västmanlands Hospital Västerås — Västerås, Sweden (Not_yet_recruiting)
Study contacts
- Study coordinator: Erik Osterman, MD PhD
- Email: erik.osterman@akademiska.se
- Phone: +460186110000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.