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Prophylactic ciNPWT for High-risk Diabetic Patients in Acute Laparotomy Wounds

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Study Aim

This study aims to prevent surgical site infections in high-risk diabetic patients undergoing emergency laparotomy, by evaluating the effectiveness of prophylactic ciNPWT.

What is being tested

Prophylactic/Incisional Negative Pressure Wound Therapy

Device
Who is being recruted

Diabetes Mellitus+2

+ Endocrine System Diseases

+ Metabolic Diseases

+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorSemmelweis University
Study ContactBalázs BánkyMore contacts
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 22, 2026

Actual date on which the first participant was enrolled.

This clinical trial aims to investigate the effectiveness of a treatment called Prophylactic Negative Pressure Wound Therapy (ciNPWT) in high-risk diabetic patients who have undergone acute laparotomy, a type of abdominal surgery. Surgical site infections (SSIs) are a significant challenge in many surgical disciplines, despite preventive measures. Abdominal surgeries, especially those involving bowel resections, carry a higher risk of wound infections. For diabetic patients, uncontrolled diabetes can lead to complications, including wound infections, due to factors like tissue hypoxia and cellular dysfunction. This study is important as it could help improve care for diabetic patients undergoing abdominal surgeries by reducing the risk of SSIs. During the study, participants will receive ciNPWT treatment, which involves applying continuous or intermittent negative pressure to the surgical incision. This therapy increases tissue vascularization, reduces edema, and promotes wound healing by removing necrotic tissue debris and stimulating granulation tissue formation. The primary outcome measured in this study is the incidence of SSI, evaluated through clinical assessment and medical records. The study aims to determine if ciNPWT can reduce the number of patients developing surgical site infections after emergency laparotomy.

Official TitleInvestigation of the Effectiveness of Prophylactic NPWT (ciNPWT) in High-risk Diabetic Patients With Acute Laparotomy Wounds - A Randomized, Prospective Clinical Trial
Principal SponsorSemmelweis University
Study ContactBalázs BánkyMore contacts
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

110 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
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).

4 exclusion criteria prevent from participating
Pregnancy,

Refusal to participate in the study.

Life expectancy of less than 30 days,

Disseminated cancer (irresectable distant metastasis, peritoneal carcinomatosis),

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Semmelweis University, Department of Surgery, Transplantation and Gastroenterology

Budapest, HungaryOpen Semmelweis University, Department of Surgery, Transplantation and Gastroenterology in Google Maps
Recruiting soonOne Study Center
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