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Radial Forearm Donor Site Closure

Primary Purpose

Oral Cancer, Oral Cavity Cancer, Donor Site Complication

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Split-Thickness Skin Graft for Radial Forearm Donor Site Closure
Hatchet Flap for Radial Forearm Donor Site Closure
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cancer focused on measuring Oral Cancer, Oral Cavity Cancer, Radial Forearm, Donor Site, Surgical Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

STSG arm

Hatchet flap arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
First Decision Regret Scale (DRS) Measure
A questionnaire measuring a patient's decisional regret related to receiving the surgery. Responses are measured on a 5-point Likert scale, ranging from extreme decisional regret (5) to no decisional regret (1).
Second DRS Measure
A questionnaire measuring a patient's decisional regret related to receiving the surgery. Responses are measured on a 5-point Likert scale, ranging from extreme decisional regret (5) to no decisional regret (1).

Secondary Outcome Measures

Localized Hematoma at Donor Site
A severe pooling of blood at the donor site.
Donor Site Infection
Infection at the donor site or anywhere along the forearm scar.
Donor Site Wound Dehiscence
A re-opening of the donor site wound.
Donor Site Tendon Exposure
Exposure of the forearm tendons at the donor site.
Donor Site Skin Necrosis
Significant amount of dead or dying skin tissue overlying or abutting the donor site and scar.
Donor Site Contractures
A persistent tightening or contraction of skin, ligaments, tendons, or muscles at the forearm donor site.
Keloid Scarring at Donor Site Wound
Excessive scar tissue formation along the donor site wound.
Divot Formation into Skin at Donor Site
Visible and persistent depressions into the skin surface of the forearm.
Skin Graft Irregularities at Donor Site
Additional irregularities such as bumps, roughness, or changes to colour will be recorded.

Full Information

First Posted
January 3, 2023
Last Updated
June 5, 2023
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05740033
Brief Title
Radial Forearm Donor Site Closure
Official Title
Functional and Aesthetic Outcomes of Radial Forearm Free Flap Closure Using Split-Thickness Skin Graft vs Primary Closure; a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The radial forearm free flap (RFFF), introduced by Yang et al. in 1981, 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. Since the survival rate of the RFFF has reached more than 95%, the clinical focus has gradually shifted to the postoperative quality of life, particularly in terms of donor site morbidity. Concerns about aesthetic and functional morbidity at the donor site have given rise to various techniques of closing the donor site of a RFFF. Many possibilities of donor site closures have been described, ranging from direct closure to skin grafting, tissue expansion, use of acellular dermal matrix and local flaps. Each of these techniques has its own advantages and drawbacks and the debate regarding the optimal method for closing the RFFF donor site continues. Split-thickness skin graft (STSG) is a very thin strip of skin that is typically taken from the upper thigh and is the most commonly used method to cover the forearm after taking the RFFF. Advantages of this technique include reducing the amount of tension that is on the forearm which may lead to a better scar and better mobility while disadvantages include the need of an additional scar on the thigh and possible mismatch of the color of the skin graft when compared to the forearm. Due to these potential limitations, surgeons have attempted to close the forearm directly by means of local flaps, which use nearby skin, soft tissue, and blood vessels to cover the forearm. The hatchet flap is a triangular local rotation flap, first described by Emmet in 1977, with a greater or lesser degree of advancement and with a back cut at the base of the flap through which it derives its vascular supply. This method may allow for quicker wound healing by primary intention and improved coverage of the tendons which should theoretically decrease donor site morbidity; however, since only tissue from the forearm is used this may lead to increased tension and therefore increased scar formation. Risks and complications for both types of closure are the same which include bleeding, infection, hypertrophic scars, tendon exposure, divot formation, irregular skin graft surface, prolonged wound healing, and loss of skin graft. There are only a few studies on the functional and visual outcomes of forearm closure after RFFF removal using the hatchet flap or similar local flaps, warranting the need for further studies on these closure techniques. It is hypothesized that donor site closure using the STSG flap will result in greater functional and aesthetic outcomes for the radial forearm donor site as measured by an improved scores to the 3 given questionnaires. Post-operative complication rates are also hypothesized to be lower for STSG flap closure when compared to hatchet flap closure. The literature currently remains in a state of clinical equipoise, and at the study site (Vancouver General Hospital) the STSG and hatchet flap are the two most common methods of donor site closure. Based on a retrospective data analysis at the study site, functional and patient-reported scar aesthetic outcomes were improved for STSG flap closure patients when compared to hatchet flap patients. As a retrospective analysis, objective assessments of the scar could not be performed, nor could the immediate post-operative outcomes be taken and compared over a consistent post-operative time frame schedule. This study aims to address this knowledge gap by conducting a parallel-group randomized controlled trial for the study site's two common donor site closure techniques, STSG and hatchet flap.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer, Oral Cavity Cancer, Donor Site Complication
Keywords
Oral Cancer, Oral Cavity Cancer, Radial Forearm, Donor Site, Surgical Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will have two arms: one with participants receiving a split-thickness skin graft from the thigh to close the radial forearm donor site, and the other using a local (hatchet) flap to close this site. These two arms will be populated randomly and in parallel.
Masking
None (Open Label)
Masking Description
Participants will become aware of what arm they were randomly assigned to: those in the STSG arm will be to see their additional thigh scar; those in the local flap arm will lack this scar. As such, participants will only be blinded prior to their treatment. The surgeons may not be blinded as they will be performing the procedure on the participants and following up with them as per standard of care post-operatively.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STSG arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hatchet flap arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Split-Thickness Skin Graft for Radial Forearm Donor Site Closure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hatchet Flap for Radial Forearm Donor Site Closure
Intervention Description
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 Information:
Title
First Michigan Hand Outcomes Questionnaire (MHOQ) Measure
Description
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.
Title
Second MHOQ Measure
Description
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.
Title
First Patient and Observer Scale Assessment Scale (POSAS) Measure
Description
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.
Title
Second POSAS Measure
Description
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.
Title
First Decision Regret Scale (DRS) Measure
Description
A questionnaire measuring a patient's decisional regret related to receiving the surgery. Responses are measured on a 5-point Likert scale, ranging from extreme decisional regret (5) to no decisional regret (1).
Time Frame
Measure documented at 1 month post-surgery.
Title
Second DRS Measure
Description
A questionnaire measuring a patient's decisional regret related to receiving the surgery. Responses are measured on a 5-point Likert scale, ranging from extreme decisional regret (5) to no decisional regret (1).
Time Frame
Measure documented between 3-6 months post-surgery.
Secondary Outcome Measure Information:
Title
Localized Hematoma at Donor Site
Description
A severe pooling of blood at the donor site.
Time Frame
Patients will be monitored for 6 months post-operatively.
Title
Donor Site Infection
Description
Infection at the donor site or anywhere along the forearm scar.
Time Frame
Patients will be monitored for 6 months post-operatively.
Title
Donor Site Wound Dehiscence
Description
A re-opening of the donor site wound.
Time Frame
Patients will be monitored for 6 months post-operatively.
Title
Donor Site Tendon Exposure
Description
Exposure of the forearm tendons at the donor site.
Time Frame
Patients will be monitored for 6 months post-operatively.
Title
Donor Site Skin Necrosis
Description
Significant amount of dead or dying skin tissue overlying or abutting the donor site and scar.
Time Frame
Patients will be monitored for 6 months post-operatively.
Title
Donor Site Contractures
Description
A persistent tightening or contraction of skin, ligaments, tendons, or muscles at the forearm donor site.
Time Frame
Patients will be monitored for 6 months post-operatively.
Title
Keloid Scarring at Donor Site Wound
Description
Excessive scar tissue formation along the donor site wound.
Time Frame
Patients will be monitored for 6 months post-operatively.
Title
Divot Formation into Skin at Donor Site
Description
Visible and persistent depressions into the skin surface of the forearm.
Time Frame
Patients will be monitored for 6 months post-operatively.
Title
Skin Graft Irregularities at Donor Site
Description
Additional irregularities such as bumps, roughness, or changes to colour will be recorded.
Time Frame
Patients will be monitored for 6 months post-operatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eitan Prisman, MD, FRCSC
Phone
6048754126
Email
eitan.prisman@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Harkaran S Dial
Phone
6048754111
Ext
22935
Email
harkaran.dial@vch.ca
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Pan
Phone
(604) 875-4111
Ext
22935
Email
diane.pan@vch.ca

12. IPD Sharing Statement

Learn more about this trial

Radial Forearm Donor Site Closure

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