Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Incisional Negative Pressure Wound Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NPWT | Device | — | UNRESOLVED |
| Traditional wound care | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: negative pressure wound therapy(PREVENA™ Incision Management System)
- description
- Wound of ALT donor site will be cared under PREVENA™ Incision Management System
- interventionNames
- Device: NPWT
- type
- PLACEBO_COMPARATOR
- label
- Placebo Comparator: conventional dressing
- description
- Wound of ALT donor site will be cared by traditional dressing and care.
- interventionNames
- Device: Traditional wound care
Primary outcomes (1)
- measure
- Development of wound dehiscence or other wound complications in the ALT flap donor site area
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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: 1. The donor site of ALT flap can be closed primarily. 2. Age≥20 years and \<80 years 3. ALT flap size measuring more than 6 cm in width 4. 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: 1. he donor site of ALT flap can not be closed primarily. 2. Uncontrolled diabetes mellitus, as measured by HbA1c≥10% 3. Under renal replacement therapy for more than 1 year. 4. Pregnant woman
References
Publications (0)
Data not yet available