Prophylactic Use of ciNPWT in Gynecologic Laparotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: closed incision negative pressure wound therapy (ciNPWT).
- Who it may be relevant to
- Registry conditions: Surgical Site Infection (SSI), Wound Healing Complication, Seroma, Hematoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Implementation of Prophylactic Negative Pressure Wound Therapy (ciNPWT) in High-Risk Patients in Gynecologic Oncology: A Prospective Feasibility Study and Nested Qualitative Analysis
Overview
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
- 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
Primary outcome measures
- Feasibility of targeted prophylactic ciNPWT [Time frame: Up to 30 postoperative days]
- Feasibility of targeted prophylactic ciNPWT [Time frame: Up to 30 postoperative days]
- Feasibility of targeted prophylactic ciNPWT [Time frame: Up to 30 postoperative days]
Secondary outcome measures (4)
- Objective assessment of wound healing [Time frame: Up to 30 postoperative days.]
- Subjective assessment of pain [Time frame: Up to 30 postoperative days]
- Subjective assessment of quality of life [Time frame: Up to 30 postoperative days]
- Subjective treatment satisfaction [Time frame: Up to 30 postoperative days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07645547 · 202511 P02