Radial Forearm Donor Site Closure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of British Columbia
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 or older
Oral cavity disease (malignant or benign) requiring radial forearm free flap reconstruction
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Split-Thickness Skin Graft for Radial Forearm Donor Site Closure
Procedure/SurgeryThis 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.
Hatchet Flap for Radial Forearm Donor Site Closure
Procedure/SurgeryThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: STSG armActive comparator 1 intervention
Group B: Hatchet flap armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
First Michigan Hand Outcomes Questionnaire (MHOQ) Measure
A questionnaire that measures symptoms, function, aesthetics, and patient satisfaction in regards to the function of their hands. Responses are recorded on a 5-point Likert scale ranging from very good (1) to very poor (5).
Time frame
Measure documented at 1 month post-surgery.2
Second MHOQ Measure
A questionnaire that measures symptoms, function, aesthetics, and patient satisfaction in regards to the function of their hands. Responses are recorded on a 5-point Likert scale ranging from very good (1) to very poor (5).
Time frame
Measure documented between 3-6 months post-surgery.3
First Patient and Observer Scale Assessment Scale (POSAS) Measure
A questionnaire measuring both the patient's aesthetic perception and the trial coordinator's aesthetic and physical assessment of the scar formation along the donor site wound. Responses to questions are measured on a 10-point Likert scale ranging from the worst scarring imaginable (10) to the best scar imaginable (feels like normal skin, not scar tissue; 1).
Time frame
Measure documented at 1 month post-surgery.4
Second POSAS Measure
A questionnaire measuring both the patient's aesthetic perception and the trial coordinator's aesthetic and physical assessment of the scar formation along the donor site wound. Responses to questions are measured on a 10-point Likert scale ranging from the worst scarring imaginable (10) to the best scar imaginable (feels like normal skin, not scar tissue; 1).
Time frame
Measure documented between 3-6 months post-surgery.Secondary outcomes
1
Localized Hematoma at Donor Site
A severe pooling of blood at the donor site.
Time frame
Patients will be monitored for 6 months post-operatively.2
Donor Site Infection
Infection at the donor site or anywhere along the forearm scar.
Time frame
Patients will be monitored for 6 months post-operatively.3
Donor Site Wound Dehiscence
A re-opening of the donor site wound.
Time frame
Patients will be monitored for 6 months post-operatively.4
Donor Site Tendon Exposure
Exposure of the forearm tendons at the donor site.
Time frame
Patients will be monitored for 6 months post-operatively.Sponsors and contacts
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Source ClinicalTrials.gov