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NCT07645547
Prophylactic Use of ciNPWT in Gynecologic Laparotomy
Conditions: Surgical Site Infection (SSI), Wound Healing Complication, Seroma, Hematoma, Dehiscence
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: University Hospital Hradec Kralove
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
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.
Source: ClinicalTrials.gov (NCT07645547). StuddyBuddy aggregates publicly available trial information.