RecruitingNot Applicable

Radial Forearm Donor Site Closure

Canada120 participantsStarted 2023-02-01

Plain-language summary

The radial forearm free flap (RFFF) is widely used in head and neck reconstruction. Its thinness, pliability, pedicle length, and vessel size are particularly suited for oropharyngeal and oral cavity reconstruction. Concerns about aesthetic and functional morbidity at the donor site have given rise to various techniques of closing the donor site, two of which are the split-thickness skin graft (STSG), taken from the thigh, and the hatchet flap, which uses a local flap within the radial forearm. This RCT will determine whether retrospectively reported improvements to aesthetic and functional outcomes for STSG patients are greater compared to hatchet flap patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

First Michigan Hand Outcomes Questionnaire (MHOQ) Measure

Timeframe: Measure documented at 1 month post-surgery.

Second MHOQ Measure

Timeframe: Measure documented between 3-6 months post-surgery.

First Patient and Observer Scale Assessment Scale (POSAS) Measure

Timeframe: Measure documented at 1 month post-surgery.

Second POSAS Measure

Timeframe: Measure documented between 3-6 months post-surgery.

First Decision Regret Scale (DRS) Measure

Timeframe: Measure documented at 1 month post-surgery.

Second DRS Measure

Timeframe: Measure documented between 3-6 months post-surgery.

Trial details

NCT IDNCT05740033

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Eitan Prisman, MD, FRCSC

6048754126 eitan.prisman@ubc.ca

View on ClinicalTrials.gov More Oral Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

First Michigan Hand Outcomes Questionnaire (MHOQ) Measure

Timeframe: Measure documented at 1 month post-surgery.

Second MHOQ Measure

Timeframe: Measure documented between 3-6 months post-surgery.

First Patient and Observer Scale Assessment Scale (POSAS) Measure

Timeframe: Measure documented at 1 month post-surgery.

Second POSAS Measure

Timeframe: Measure documented between 3-6 months post-surgery.

First Decision Regret Scale (DRS) Measure

Timeframe: Measure documented at 1 month post-surgery.

Second DRS Measure

Timeframe: Measure documented between 3-6 months post-surgery.