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NCT Number: NCT07645547

Prophylactic Use of ciNPWT in Gynecologic Laparotomy

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

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Key information

Conditions

Surgical Site Infection (SSI) Dehiscence Hematoma Hemorrhage Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Seroma Surgical Wound Infection Wound Healing Complication Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Feasibility of targeted prophylactic ciNPWT

    Time frame: Up to 30 postoperative days

    Feasibility of prophylactic ciNPWT described as: Recruitment rate (%)

  2. Feasibility of targeted prophylactic ciNPWT

    Time frame: Up to 30 postoperative days

    Feasibility of prophylactic ciNPWT described as: Completion rate (%)

  3. Feasibility of targeted prophylactic ciNPWT

    Time frame: Up to 30 postoperative days

    Feasibility of prophylactic ciNPWT described as: Safety and technical complications (description)

Secondary outcomes

  1. Objective assessment of wound healing

    Time frame: Up to 30 postoperative days.

    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).

  2. Subjective assessment of pain

    Time frame: Up to 30 postoperative days

    Pain assessment using the Numeric Rating Scale (NRS, scale 0-10, higher number = worse outcome) at rest and during movement.

  3. Subjective assessment of quality of life

    Time frame: Up to 30 postoperative days

    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).

  4. Subjective treatment satisfaction

    Time frame: Up to 30 postoperative days

    Treatment satisfaction and patient experience via an original questionnaire (scale 8-40, higher number = worse outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Klara Balcarova

CONTACT

[email protected]

+420731964956

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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