Active — Not RecruitingNot Applicable

The Use of iNPWT for Management of ALT Flap Donor Site Wound

Taiwan138 participantsStarted 2021-04-08

Plain-language 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 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.

Who can participate

Age range20 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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

✕. 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

What they're measuring

Development of wound dehiscence or other wound complications in the ALT flap donor site area

Timeframe: 30 days

Trial details

NCT IDNCT04762732

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Incisional Negative Pressure Wound Therapy trials