Investigation of the Effectiveness of Prophylactic NPWT (ciNPWT) in High-risk Diabetic Patients With Acute Laparotomy Wounds

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSemmelweis University

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

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators