NCT04762732Active, not recruiting
The Use of iNPWT for Management of ALT Flap Donor Site Wound
The Use of Incisional Negative Pressure Wound Therapy for Management of Anterolateral Thigh Flap Donor Site Wound: A Prospective, Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
Primary closure or skin grafting of the donor site after harvest of a anterolateral thigh flap (ALT) is associated with significant morbidity. Incisional negative pressure wound therapy (NPWT) may decrease complications in high-risk incisions. Successful use of NPWT has been reported in the treatment of ALT flap donor site wounds in a retrospective observational study, but no prospective study of NPWT application in the ALT flap donor site has been reported. This study aims to assess the incidence of complications at ALT flap donor site with an incisional NPWT device, PREVENA™. A prospective, controlled, pair-matched study has been designed to compare the effectiveness, complication rate, and scar quality of ALT flap donor site between using incisional NPWT and conventional bolster dressing.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 138 (actual)
- First submitted
- 17 Feb 2021
- Start date
- 8 Apr 2021
- Primary completion date
- Jun 2026
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT04762732
What you commit to
- Study type: Interventional
- Participants enrolled: 138
- From 8 Apr 2021 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Under renal replacement therapy for more than 1 year.
Lab values
- he donor site of ALT flap can not be closed primarily.
- Uncontrolled diabetes mellitus, as measured by HbA1c≥10%
Other
- Pregnant woman
Criteria the registry did not label
- The study is designed as a prospective randomized clinical trial. This study aims to enroll patients who require a free ALT flap for head and neck reconstruction. Inclusion criteria are as follows:
- The donor site of ALT flap can be closed primarily.
- Age≥20 years and \<80 years
- ALT flap size measuring more than 6 cm in width
- Patients will be required to understand and be willing to participate in the trial and be able to comply with the follow-up visits
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.