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.
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).
Pregnancy,
Disseminated cancer (irresectable distant metastasis, peritoneal carcinomatosis),
Life expectancy of less than 30 days,
Refusal to participate in the study.
Parallel
Prophylactic/Incisional Negative Pressure Wound Therapy
DeviceNegative Pressure Wound Therapy device used on closed laparotomy wound to prevent SSI.
Incidence of SSI
The ratio of patients developing surgical site infection after emergency laparotomy. Unit of Measure: Number and percentage of patients Measurement Tool : Clinical assessment and medical records
Length of Intensive Care Unit (ICU) stay
Number of days spent in the Intensive Care Unit following surgery. Unit of Measure: Days Measurement Tool: Hospital medical records
Length of hospital stay
Total number of days of hospitalization following surgery. Unit of Measure: Days Measurement Tool: Hospital medical records
Incidence of abdominal wall dehiscence
Occurrence of abdominal wall dehiscence following surgery. Unit of Measure: Number and percentage of patients Measurement Tool : Clinical assessment and medical records
Reoperation rate
Proportion of patients requiring at least one reoperation following the index procedure. Unit of Measure: Number and percentage of patients (Yes/No) Measurement Tool: medical records
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