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Local Flap
Skin Graft vs. Hatchet Flap for Donor Site Closure
N/A
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measure documented between 3-6 months post-surgery.
Awards & highlights
Study Summary
This trial will compare two techniques to close the donor site in head and neck reconstruction: split-thickness skin graft (STSG) and hatchet flap. It will examine if one provides better aesthetic and functional outcomes than the other.
Who is the study for?
This trial is for adults over 18 needing forearm flap reconstruction due to oral cavity diseases, who can handle surgery and fill out questionnaires in English. It's not for those with serious illnesses like metastatic disease, hand usage issues from conditions or scars, or women who are pregnant or breastfeeding.Check my eligibility
What is being tested?
The study compares two methods of healing the arm after a piece of it is used to reconstruct parts of the mouth affected by cancer or other diseases. One method uses skin from the thigh (STSG), while the other rearranges local tissue (hatchet flap).See study design
What are the potential side effects?
Possible side effects include discomfort at graft or flap sites, scarring, reduced arm movement, poor wound healing, and dissatisfaction with how the arm looks post-surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measure documented between 3-6 months post-surgery.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measure documented between 3-6 months post-surgery.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
First Decision Regret Scale (DRS) Measure
First Michigan Hand Outcomes Questionnaire (MHOQ) Measure
First Patient and Observer Scale Assessment Scale (POSAS) Measure
+3 moreSecondary outcome measures
Divot Formation into Skin at Donor Site
Donor Site Contractures
Donor Site Infection
+6 moreTrial Design
2Treatment groups
Active Control
Group I: STSG armActive Control1 Intervention
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.
Group II: Hatchet flap armActive Control1 Intervention
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.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,466,998 Total Patients Enrolled
3 Trials studying Oral Cancers
980 Patients Enrolled for Oral Cancers
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot or do not want to fill out post-surgery forms in English.I have no conditions that limit the use of both my hands.I am 18 years old or older.I have serious health issues that prevent me from having surgery.I need surgery to rebuild my mouth area using tissue from my arm.
Research Study Groups:
This trial has the following groups:- Group 1: STSG arm
- Group 2: Hatchet flap arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any additional openings for participants in this research?
"According to information accessible on clinicaltrials.gov, participants are being sought for this medical trial which was initially posted February 1st 2023 and most recently modified June 5th 2023."
Answered by AI
How many participants are being monitored for this research endeavor?
"Affirmative. According to information recorded on clinicaltrials.gov, this treatment trial is actively recruiting participants; it was initially listed on February 1st 2023 and the latest update came June 5th of that same year. 120 patients are sought after from a single medical facility."
Answered by AI
What aims are the researchers hoping to accomplish with this experiment?
"The purpose of this experiment, which will then be assessed after one month post operation, is to estimate the Second POSAS Measure. Secondary outcomes include Keloid Scarring along Donor Site Wound, contractures in the forearm donor site and irregularities such as bumps or colour changes at the skin graft's location."
Answered by AI
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