Status:
ACTIVE_NOT_RECRUITING
The Use of iNPWT for Management of ALT Flap Donor Site Wound
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Incisional Negative Pressure Wound Therapy
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
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 dec...
Detailed Description
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 dec...
Eligibility Criteria
Inclusion
- 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
- Exclusion criteria are as follows:
- he donor site of ALT flap can not be closed primarily.
- Uncontrolled diabetes mellitus, as measured by HbA1c≥10%
- Under renal replacement therapy for more than 1 year.
- Pregnant woman
Exclusion
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04762732
Start Date
April 8 2021
End Date
June 1 2026
Last Update
November 19 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100