Comparing methods for closing the radial forearm donor site after surgery
Functional and Aesthetic Outcomes of Radial Forearm Free Flap Closure Using Split-Thickness Skin Graft vs Primary Closure; a Randomized Control Trial
This study is testing two different ways to close the arm after surgery for head and neck reconstruction to see which method helps patients heal better and feel happier with their results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05740033 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates two techniques for closing the donor site after using the radial forearm free flap (RFFF) in head and neck reconstruction. The study compares the split-thickness skin graft (STSG) method, which involves taking skin from the thigh, to the hatchet flap method, which uses local tissue from the forearm. Researchers will assess aesthetic and functional outcomes reported by patients to determine which closure technique yields better results. The focus is on improving postoperative quality of life by minimizing donor site complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with oral cavity disease requiring radial forearm free flap reconstruction.
Not a fit: Patients with serious medical comorbidities or those unable to complete post-operative questionnaires may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved aesthetic and functional outcomes for patients undergoing oral cavity reconstruction.
How similar studies have performed: Previous studies have explored various donor site closure techniques, but this specific comparison of STSG and hatchet flap is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 or older * Oral cavity disease (malignant or benign) requiring radial forearm free flap reconstruction Exclusion Criteria: * 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
Where this trial is running
Vancouver, British Columbia
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Eitan Prisman, MD, FRCSC
- Email: eitan.prisman@ubc.ca
- Phone: 6048754126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.