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NCT Number: NCT04762732

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Incisional Negative Pressure Wound Therapy Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NPWT

Device

Wound of ALT donor site will be cared under PREVENA™ Incision Management System for 5 days post-operatively.

Traditional wound care

Device

Wound of ALT donor site will be covered by vaseline gauze coated with tetracycline ointment (Genuine Chemical Pharmaceutical, Tao-Yuan, Taiwan), and layers of gauze.

Primary outcomes

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

    Time frame: 30 days

    Development of wound dehiscence or other wound complications in the ALT flap donor site area during the first 6 weeks postoperatively. Wound dehiscence is defined as the splitting apart or rupturing of the margins of a previously closed wound along some or all of its length. Surgical site infection (SSI) was reported according to the revised criteria outlined by the Centers for Disease Control and Prevention (CDC), USA. To achieve a higher degree of objectivity, we will also adopt the modified ASEPSIS score criteria and definitions. The primary outcomes are assessed at the standardized follow-up visits by nurses and physicians in the hospital or in the outpatient clinic, who are not connected to the study and blinded to dressing allocation. The presence of dehiscence/infection at the ALT flap donor site, total or partial skin graft loss, and the need for another surgical procedure to the donor site are recorded.

Secondary outcomes

  1. donor site scar quality

    Time frame: 6 months

    irst, we will use the Vancouver Scar Scale (VSS) for evaluation at post-operative 6 months. The VSS assesses four variables: vascularity, height/thickness, pliability and pigmentation. Each variable includes ranked subscales that are summed to obtain a total score ranging from 0 to 13, with 0 representing normal skin and 13 representing maximum alterations of the skin. The Patient and Observer Scar Assessment Scale (POSAS), which is a reliable and consistent tool used to assess scar quality, will also be employed.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Use of Incisional Negative Pressure Wound Therapy for Management of Anterolateral Thigh Flap Donor Site Wound: A Prospective, Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2021
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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