Recruiting

Radial Forearm

Sponsor:

University of British Columbia

Code:

NCT05740033

Conditions

Oral Cancer

Oral Cavity Cancer

Donor Site Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Split-Thickness Skin Graft for Radial Forearm Donor Site Closure

Hatchet Flap for Radial Forearm Donor Site Closure

Study Details

Brief 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.

Conditions

Oral Cancer

Oral Cavity Cancer

Donor Site Complication

Study ID

NCT05740033

Start date

Feb 1, 2023

Status verified date

Jun, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: STSG arm

Patient demographics will be recorded during the enrollment visit. During the participant's surgery in which the radial forearm free flap (RFFF) has been used, surgeons will perform a split-thickness thigh graft to close the forearm donor site. A photograph will be taken of the participants' forearm upon the removal of the dressing and splint.

On each of the two follow-up clinic visits, another photo will be taken of the forearm scar and patient-reported outcome questionnaires will be provided for completion.

active comparator: Hatchet flap arm

Patient demographics will be recorded during the enrollment visit. The hatchet flap closure of the forearm donor site will be performed following the RFFF's usage. A photograph will be taken of the participants' forearm upon the removal of the dressing and splint.

On each of the two follow-up clinic visits, another photo will be taken of the forearm scar and patient-reported outcome questionnaires will be provided for completion.

Interventions

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.

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.

Primary outcome measure

  • First Michigan Hand Outcomes Questionnaire (MHOQ) Measure [ Time Frame: Measure documented at 1 month post-surgery. ]
  • Second MHOQ Measure [ Time Frame: Measure documented between 3-6 months post-surgery. ]
  • First Patient and Observer Scale Assessment Scale (POSAS) Measure [ Time Frame: Measure documented at 1 month post-surgery. ]
  • Second POSAS Measure [ Time Frame: Measure documented between 3-6 months post-surgery. ]
  • First Decision Regret Scale (DRS) Measure [ Time Frame: Measure documented at 1 month post-surgery. ]
  • Second DRS Measure [ Time Frame: Measure documented between 3-6 months post-surgery. ]

Central Contacts and Locations

Central contacts

Eitan Prisman, MD, FRCSC

6048754126eitan.prisman@ubc.ca

Tayo Steininger

6048754111tstein12@student.ubc.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Tayo Steininger

(604) 875-4111tstein12@student.ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Jun 12, 2025

Last verified

Jun, 2025

Keywords

  • Oral Cancer
  • Oral Cavity Cancer
  • Radial Forearm
  • Donor Site
  • Surgical Complications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-06-12.