Clinical trial NCT04762732: The Use of iNPWT for Management of ALT Flap Donor Site Wound
Official title: The Use of Incisional Negative Pressure Wound Therapy for Management of Anterolateral Thigh Flap Donor Site Wound: A Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incisional Negative Pressure Wound Therapy
Keywords: free flap, head and neck cancer, wound care
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Development of wound dehiscence or other wound complications in the ALT flap donor site area
timeFrame: 6 weeks
Secondary outcomes:
measure: donor site scar quality
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Division of Plastic Surgery, Department of Surgery, National Taiwan University Hospital
name: Nai-Chen Cheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: