Comparing Split-Thickness Skin Graft for Radial with Hatchet Flap for Radial Forearm Donor for oral cancer
Official title: Radial Forearm Donor Site Closure
Functional and Aesthetic Outcomes of Radial Forearm Free Flap Closure Using Split-Thickness Skin Graft vs Primary Closure; a Randomized Control Trial
- 2 groups
- One site, in Vancouver
- Recruiting
Interventions
- Medical procedure
Split-Thickness Skin Graft for Radial Forearm Donor Site Closure
This method is performed by harvesting a 0.014-inch skin graft harvested from the anterolateral thigh on the side of the RFFF to reconstruct the forearm donor site. This skin graft is then used to cover the donor defect. The skin graft is sutured in place with 4-0 chromic suture, and a standard bolster dressing will be applied, and a partial splint will be left in place for five days post-operation.
- Medical procedure
Hatchet Flap for Radial Forearm Donor Site Closure
The hatchet flap closures will be performed based on prior description by Lane et al. (12), except no drain is placed in situ. A back cut of 3 to 4 cm is made to aid closure (Figure 1). Tension will be minimized by maintaining the wrist in flexion. A mepore dressing will be applied to the donor site post-operatively for two days.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
Eligibility Criteria
See who this study is looking for6 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Adults aged 18 or older
- +Oral cavity disease (malignant or benign) requiring radial forearm free flap reconstruction
Exclusion
- −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
- −Serious medical comorbidities including metastatic disease or other contraindications to surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Split-Thickness Skin Graft for Radial Forearm Donor SiteTrial siteA hospital or clinic where a study is actually run.Read more → Closure.
Registry label: A: STSG arm
Group B, the comparison group, receives Hatchet Flap for Radial Forearm Donor Site Closure.
Registry label: B: Hatchet flap arm
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 120 people.
The study is currently expected to finish around December 2025.
The main measurement is taken over: Measure documented at 1 month post-surgery.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
First Michigan Hand Outcomes Questionnaire (MHOQ) Measure — measured over Measure documented at 1 month post-surgery.
Second MHOQ Measure — measured over Measure documented between 3-6 months post-surgery.
First Patient and Observer Scale Assessment Scale (POSAS) Measure — measured over Measure documented at 1 month post-surgery.
Second POSAS Measure — measured over Measure documented between 3-6 months post-surgery.
The study lists 2 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05740033 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Split-Thickness Skin Graft for Radial Forearm Donor Site ClosureProcedure
This method is performed by harvesting a 0.014-inch skin graft harvested from the anterolateral thigh on the side of the RFFF to reconstruct the forearm donor site. This skin graft is then used to cover the donor defect. The skin graft is sutured in place with 4-0 chromic suture, and a standard bolster dressing will be applied, and a partial splint will be left in place for five days post-operation.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Hatchet Flap for Radial Forearm Donor Site ClosureProcedure
The hatchet flap closures will be performed based on prior description by Lane et al. (12), except no drain is placed in situ. A back cut of 3 to 4 cm is made to aid closure (Figure 1). Tension will be minimized by maintaining the wrist in flexion. A mepore dressing will be applied to the donor site post-operatively for two days.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Measure documented at 1 month post-surgery..
The study as a whole is currently expected to finish around 2025-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 120 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.