About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Pregnancy,
Disseminated cancer (irresectable distant metastasis, peritoneal carcinomatosis),
Life expectancy of less than 30 days,
Refusal to participate in the study.
Trial design
Treatments tested in this trial
- Prophylactic/Incisional Negative Pressure Wound Therapy