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

NCT07392853 | Not Yet Recruiting DMC

• 1 other identifier: BM/30843-3/2025
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes (Insulin-requiring, Type 1 or Type 2)

Keywords

abdominal surgery, SSI, diabetes, emergency surgery; ciNPWT

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Secondary Outcomes (7)

• Length of Intensive Care Unit (ICU) stay

  30 days

• Length of hospital stay

  30 days

• Incidence of abdominal wall dehiscence

  30 days

• Reoperation rate

  30 days

• Number of reoperations per patient

  30 days

Study Arms (2)

ciNPWT

EXPERIMENTAL

Group of patients being treated with prophylactic NPWT after emergency laparotomy.

Device: Prophylactic/Incisional Negative Pressure Wound Therapy

Control

NO INTERVENTION

Group of patients being treated with "regular" wound dressing.

Interventions

Prophylactic/Incisional Negative Pressure Wound Therapy DEVICE

Negative Pressure Wound Therapy device used on closed laparotomy wound to prevent SSI.

ciNPWT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Pregnancy,
• Disseminated cancer (irresectable distant metastasis, peritoneal carcinomatosis),
• Life expectancy of less than 30 days,
• Refusal to participate in the study.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University, Department of Surgery, Transplantation and Gastroenterology

Budapest, 1082, Hungary

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Balázs Bánky

CONTACT

+36-20-825-8915; bankybalazs@gmail.com

Andras Herczeg

CONTACT

+36-20-670-1721; herczeg.andras.ivan@semmelweis.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: surgeon specialist

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 6, 2026
• Study Start: February 22, 2026
• Primary Completion: February 22, 2026
• Study Completion: March 22, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)