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

National Taiwan University

Status: Active, not recruiting

Conditions: Incisional Negative Pressure Wound Therapy

Treatments: Device: NPWT; Device: Traditional wound care

Study type: Interventional

Funder types: Other

Identifiers

NCT04762732

202006043RIPD

Details and patient eligibility

About

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.

Full 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 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 assessed 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.

Enrollment: 138 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

138 participants in 2 patient groups, including a placebo group

Experimental: negative pressure wound therapy(PREVENA™ Incision Management System)

Experimental group

Description:

Wound of ALT donor site will be cared under PREVENA™ Incision Management System

Treatment:

Device: NPWT

Placebo Comparator: conventional dressing

Placebo Comparator group

Description:

Wound of ALT donor site will be cared by traditional dressing and care.

Treatment:

Device: Traditional wound care