Prophylactic Use of ciNPWT in Gynecologic Laparotomy

Implementation of Prophylactic Negative Pressure Wound Therapy (ciNPWT) in High-Risk Patients in Gynecologic Oncology: A Prospective Feasibility Study and Nested Qualitative Analysis

This is a prospective, open-label, non-randomized interventional feasibility study with a nested qualitative analysis. The study exploratively verifies the feasibility of targeted prophylactic closed incision negative pressure wound therapy (ciNPWT) in clinical practice for patients with a high predicted risk of wound healing complications and compares the 30-day incidence of postoperative complications with standard dressing.

Participants will:

• Get ciNPWT or standard dressing after planned laparotomy
• Answer the questionairs about qualite of life
• Will visit the clinic 30 days after surgery to see the final result

Study Overview

• Status: Not yet recruiting
• Conditions: Hematoma; Seroma; Dehiscence; Wound Healing Complication; Surgical Site Infection (SSI)
• Intervention / Treatment: Device: closed incision negative pressure wound therapy (ciNPWT)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klara Balcarova; Phone Number: +420731964956; Email: klara.balcarova@fnhk.cz

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adult female patients scheduled for planned abdominal surgery for gynecologic or gynecologic-oncologic indications.

Identification as "high-risk" for wound healing complications based on a clinical risk screening at admission.

Signed informed consent.

Exclusion Criteria:

• Failure to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preventive ciNPWT	Device: closed incision negative pressure wound therapy (ciNPWT); targeted prophylactic closed incision negative pressure wound therapy in clinical practice for patients with a high predicted risk of wound healing complications
No Intervention: Standard dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of targeted prophylactic ciNPWT	Feasibility of prophylactic ciNPWT described as: Recruitment rate (%)	Up to 30 postoperative days
Feasibility of targeted prophylactic ciNPWT	Feasibility of prophylactic ciNPWT described as: Completion rate (%)	Up to 30 postoperative days
Feasibility of targeted prophylactic ciNPWT	Feasibility of prophylactic ciNPWT described as: Safety and technical complications (description)	Up to 30 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective assessment of wound healing	Objective assessment of wound healing using the ASEPSIS (Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay = ASEPSIS) scoring system (scale 0-100, higher number = worse outcome).	Up to 30 postoperative days.
Subjective assessment of pain	Pain assessment using the Numeric Rating Scale (NRS, scale 0-10, higher number = worse outcome) at rest and during movement.	Up to 30 postoperative days
Subjective assessment of quality of life	Patient-Reported Outcomes including the 5-level version of Quality of life EuroQol Group questionnaire (EQ-5D-5L, scale 5-25, higher number = worse outcome).	Up to 30 postoperative days
Subjective treatment satisfaction	Treatment satisfaction and patient experience via an original questionnaire (scale 8-40, higher number = worse outcome).	Up to 30 postoperative days

Collaborators and Investigators

• Sponsor: University Hospital Hradec Kralove

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: laparotomy; feasibility; surgical site infection; PROMs; SSI; ciNPWT; ASEPSIS
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Hemorrhage; Inflammation; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection; Hematoma; Seroma
• Other Study ID Numbers: 202511 P02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No