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

Investigation of the Effectiveness of Prophylactic NPWT (ciNPWT) in High-risk Diabetic Patients With Acute Laparotomy Wounds - A Randomized, Prospective Clinical 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes (Insulin-requiring, Type 1 or Type 2)
• Intervention / Treatment: Device: Prophylactic/Incisional Negative Pressure Wound Therapy

Detailed Description

Background and Introduction Postoperative surgical site infections (SSI) continue to represent a significant challenge across almost all surgical disciplines, despite the widespread implementation of well-established aseptic and preventive measures. Abdominal surgery, in particular, presents an inherently higher risk, considering the nature of the procedures (e.g., surgeries involving bowel resections). For emergency and urgent procedures, the rate of wound infections can reach as high as 30%, according to some literature sources.

Risk Factors for SSI Risk factors can be categorized based on the surgical procedure itself (e.g., acute/elective, bowel resection/non-resection, wound cleanliness), patient characteristics (e.g., diabetes, smoking, peripheral arterial disease, obesity, age, gender), underlying medical conditions (e.g., cancer, immunosuppressed or septic patients), and perioperative management (e.g., surgical duration, transfusion requirements, hypothermia, hyper/hypoglycemia, hypoxia, pharmacological treatments). Many of these factors are modifiable during patient care (e.g., achieving normothermia, ensuring proper asepsis during surgery, maintaining normoglycemia) or preoperatively (e.g., improving nutritional status, correcting anemia, managing chronic diseases such as diabetes and hypertension, promoting weight reduction). However, in emergency surgeries, there is often insufficient time to address these factors, significantly increasing the risk of SSI.

The Impact of Diabetes Mellitus as an SSI Risk Factor Uncontrolled diabetes is associated with a higher incidence of complications, including wound infections. Factors such as tissue hypoxia (due to diabetic micro- and macroangiopathy and impaired angiogenesis), cellular dysfunction (e.g., abnormal endothelial, macrophage, and neutrophil function), and the formation of glycotoxins (Advanced Glycation End-products or AGEs) due to hyperglycemia impair wound healing. Numerous large-scale meta-analyses have confirmed the association between diabetes and surgical wound infections . Studies across various surgical fields (e.g., cardiac surgery, orthopedics, colorectal surgery) have demonstrated that preoperative (HbA1c) and perioperative (normoglycemia) management of blood glucose levels can significantly reduce the risk of SSI .

ciNPWT (Closed Incisional, Prophylactic NPWT) as a Method for Preventing Surgical Site Infections

Negative Pressure Wound Therapy (NPWT) was initially developed in the 1990s to treat chronic, difficult-to-heal wounds (Argenta & Morykwas). The mechanism of NPWT involves the application of either continuous or intermittent negative pressure, which increases tissue vascularization, reduces edema, and promotes wound healing by removing necrotic tissue debris and stimulating granulation tissue formation. When applied prophylactically to closed surgical incisions, the available literature supports the significant reduction of septic surgical complications. Based on the results of a previously published multicenter, randomized, prospective clinical trial conducted by the investigators' research team, ciNPWT has been shown to reduce the incidence of SSIs following high-risk, urgent general abdominal surgeries (2). However, in that study, few poorly controlled diabetic patients were included, meaning no conclusions could be drawn specifically regarding this high-risk group. The effectiveness of NPWT has been largely settled in clinical debate, with numerous studies demonstrating its positive impact on wound healing. However, the cost-effectiveness of prophylactic NPWT remains an open question.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Balazs Banky; Phone Number: +36-20-825-8915; Email: bankybalazs@gmail.com
• Study Contact Backup: Name: Andras Herczeg; Phone Number: +36-20-670-1721; Email: herczeg.andras.ivan@semmelweis.hu

Study Locations

• Hungary
  • Budapest, Hungary, 1082
    • Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
    • Contact: Balazs Banky; Phone Number: +36-20-825-8915; Email: bankybalazs@gmail.com
    • Contact: Andras Herczeg; Phone Number: +36-20-670-1721; Email: herczeg.andras.ivan@semmelweis.hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:a (all criteria must apply simultaneously):

• 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).

Exclusion Criteria: (any of the following):

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ciNPWT; Group of patients being treated with prophylactic NPWT after emergency laparotomy.	Device: Prophylactic/Incisional Negative Pressure Wound Therapy; Negative Pressure Wound Therapy device used on closed laparotomy wound to prevent SSI.
No Intervention: Control; Group of patients being treated with "regular" wound dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days
Length of hospital stay	Total number of days of hospitalization following surgery. Unit of Measure: Days Measurement Tool: Hospital medical records	30 days
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	30 days
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	30 days
Number of reoperations per patient	Total number of reoperations performed per patient during the study period. Unit of Measure: Count Measurement Tool: medical records	30 days
Quality of life assessed by EQ-5D questionnaire	Health-related quality of life assessed using the EQ-5D questionnaire. Unit of Measure: Score Measurement Tool: EQ-5D questionnaire	30 days
Direct healthcare costs	Direct healthcare costs associated with postoperative care and complications. Unit of Measure: Hungarian Forint (HUF) Measurement Tool: Hospital billing and accounting records	30 days

Collaborators and Investigators

• Sponsor: Semmelweis University

Study record dates

Study Major Dates

• Study Start (Estimated): February 22, 2026
• Primary Completion (Estimated): February 22, 2026
• Study Completion (Estimated): March 22, 2026

Study Registration Dates

• First Submitted: January 24, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: abdominal surgery, SSI, diabetes, emergency surgery; ciNPWT
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: BM/30843-3/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We apply strict regulations for the secure handling of IPD during the study. The data are used solely for the purposes of the research, and sharing them with other researchers could increase privacy risks.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No