Prophylactic ciNPWT for High-risk Diabetic Patients in Acute Laparotomy Wounds
This study aims to prevent surgical site infections in high-risk diabetic patients undergoing emergency laparotomy, by evaluating the effectiveness of prophylactic ciNPWT.
Prophylactic/Incisional Negative Pressure Wound Therapy
Diabetes Mellitus+2
+ Endocrine System Diseases
+ Metabolic Diseases
Prevention Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.110 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
Budapest, HungaryOpen Semmelweis University, Department of Surgery, Transplantation and Gastroenterology in Google Maps