Actively Recruiting
Functional and Aesthetic Outcomes of Radial Forearm Free Flap Closure Using Split-Thickness Skin Graft vs Primary Closure; a Randomized Control Trial
Led by University of British Columbia · Updated on 2025-06-12
120
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
The radial forearm free flap (RFFF) is commonly used for reconstructing head and neck areas, especially the oropharynx and oral cavity, due to its favorable features like thinness and good blood supply. This research compares two common methods for closing the donor site on the forearm after RFFF surgery: the split-thickness skin graft (STSG) taken from the thigh and the hatchet flap, a local flap technique using nearby forearm tissue. The study aims to determine which method results in better aesthetic and functional outcomes and fewer complications. Participants undergo surgery where the forearm donor site is closed using either the STSG or the hatchet flap. For the STSG group, a thin skin graft from the thigh is sutured onto the forearm and covered with a dressing and splint for five days. For the hatchet flap group, a local triangular flap is rotated to close the donor site, with wrist flexion to reduce tension and a dressing applied for two days. Photographs of the donor site are taken after dressing removal and during two follow-up visits. During the study, patients complete questionnaires about hand function, scar appearance, and decision regret at both one month and between three to six months after surgery. Researchers will monitor secondary outcomes like hematoma, infection, wound healing issues, tendon exposure, skin necrosis, contractures, scarring, divot formation, and skin graft irregularities for six months. The study collects demographic data and measures outcomes to better understand donor site recovery and quality of life after these closure techniques.
CONDITIONS
Brief Title
Radial Forearm Donor Site Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 or older
- Oral cavity disease (malignant or benign) requiring radial forearm free flap reconstruction
You will not qualify if you...
- Serious medical comorbidities including metastatic disease or other contraindications to surgery
- Any pre-existing condition affecting the use of both hands, including previous major scars
- Unable or unwilling to complete post-operative questionnaires in English
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus initial post-operative care
Participants undergo surgery to close the radial forearm donor site using either a split-thickness skin graft from the thigh or a hatchet flap from the forearm. Dressing and splints are applied post-operation.
1 surgery visit (in-person)
Duration - Up to 6 months post-surgery
Participants have dressings and splints removed and photographs of the forearm scar are taken. Patient-reported outcome questionnaires are completed to assess functional and aesthetic recovery.
3 follow-up visits (in-person) including dressing removal and outcome assessments
Trial Site Locations
Total: 1 location
1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
Research Team
E
Eitan Prisman, MD, FRCSC
T
Tayo Steininger
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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