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

NCT04762732 | Active Not Recruiting

• 1 other identifier: 202006043RIPD
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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 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

Incisional Negative Pressure Wound Therapy

Keywords

free flap, head and neck cancer, wound care

Outcome Measures

Primary Outcomes (1)

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

  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.

  30 days

Secondary Outcomes (1)

• donor site scar quality

  6 months

Study Arms (2)

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

EXPERIMENTAL

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

Device: NPWT

Placebo Comparator: conventional dressing

PLACEBO COMPARATOR

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

Device: Traditional wound care

Interventions

NPWT DEVICE

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

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

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.

Placebo Comparator: conventional dressing

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Nai-Chen Cheng, PhD

  Division of Plastic Surgery, Department of Surgery, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: April 8, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-10

Locations

TW (1)