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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07645547

Enrollment

Registered

2026-06-12

Start date

2026-07-01

Completion date

2028-12-01

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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

Interventions

DEVICEclosed 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of targeted prophylactic ciNPWT	Up to 30 postoperative days	Feasibility of prophylactic ciNPWT described as: Recruitment rate (%)

Secondary

Measure	Time frame	Description
Objective assessment of wound healing	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).
Subjective assessment of pain	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.
Subjective assessment of quality of life	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).
Subjective treatment satisfaction	Up to 30 postoperative days	Treatment satisfaction and patient experience via an original questionnaire (scale 8-40, higher number = worse outcome).

Contacts

CONTACTKlara Balcarova

klara.balcarova@fnhk.cz+420731964956

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026