Prophylactic Use of ciNPWT in Gynecologic Laparotomy

NCT07645547 | Not Yet Recruiting

• 1 other identifier: 202511 P02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Surgical Site Infection (SSI); Wound Healing Complication; Seroma; Hematoma; Dehiscence

Keywords

ciNPWT; laparotomy; surgical site infection; SSI; feasibility; PROMs; ASEPSIS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Objective assessment of wound healing

  Up to 30 postoperative days.

• Subjective assessment of pain

  Up to 30 postoperative days

• Subjective assessment of quality of life

  Up to 30 postoperative days

• Subjective treatment satisfaction

  Up to 30 postoperative days

Study Arms (2)

Preventive ciNPWT

EXPERIMENTAL

Device: closed incision negative pressure wound therapy (ciNPWT)

Standard dressing

NO INTERVENTION

Interventions

closed incision negative pressure wound therapy (ciNPWT) DEVICE

targeted prophylactic closed incision negative pressure wound therapy in clinical practice for patients with a high predicted risk of wound healing complications

Preventive ciNPWT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Failure to provide informed consent.

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

MeSH Terms

Conditions

Surgical Wound Infection; Seroma; Hematoma

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Hemorrhage

Central Study Contacts

Klara Balcarova

CONTACT

+420731964956; klara.balcarova@fnhk.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-05