NCT07392853Not yet recruiting
Investigation of the Effectiveness of Prophylactic NPWT (ciNPWT) in High-risk Diabetic Patients With Acute Laparotomy Wounds
Investigation of the Effectiveness of Prophylactic NPWT (ciNPWT) in High-risk Diabetic Patients With Acute Laparotomy Wounds - A Randomized, Prospective Clinical Trial
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
The aim of this study is to evaluate the effectiveness of prophylactic Negative Pressure Wound Therapy (NPWT) in patients with diabetes mellitus undergoing laparotomy who are at high risk for Surgical Site Infections (SSI). In addition to clinical efficacy, the investigators also plan a cost effectiveness analysis to assess the applicability of this relatively high-cost intervention in a domestic healthcare setting.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 24 Jan 2026
- Start date
- 22 Feb 2026
- Primary completion date
- 22 Feb 2026
- Lead sponsor
- Semmelweis University
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07392853
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 22 Feb 2026 to the primary completion date, 22 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Disseminated cancer (irresectable distant metastasis, peritoneal carcinomatosis),
Other
- Pregnancy,
- Life expectancy of less than 30 days,
- Refusal to participate in the study.
Who the study is looking for
- Age ≥18 years,
- Undergoing urgent abdominal surgery,
- Diagnosis of diabetes mellitus either already present or newly diagnosed at admission
- High SSI risk. We consider a patient to be at high SSI risk if the operating surgeon categorizes the patient as high risk, and the patient is classified in the III-IV cleanliness category with an open abdominal surgical procedure (laparotomy). "High SSI risk" may also be assessed individually based on existing severe risk factors or using an SSI risk calculator (patients with a normal laparotomy SSI risk more than 3 times the baseline are eligible).
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Semmelweis University, Department of Surgery, Transplantation and Gastroenterology Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.