Free Tissue FlapsNCT03579277
Radial Forearm Versus the Ulnar Forearm Free Flap
A study testing Radial Forearm Free Flap and Ulnar Forearm Free Flap in people with Free Tissue Flaps, run by Indiana University at 1 site in United States.
Trial summary
This study evaluates donor site outcomes in patients receiving radial forearm free flap reconstruction versus ulnar forearm free flap reconstruction. Patients who meet criteria for forearm free flap reconstruction are randomized to receiving either radial forearm free flap or ulnar forearm free flap reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Free Tissue Flaps
- What is being tested?
- Radial Forearm Free Flap and Ulnar Forearm Free Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with planned forearm free flap reconstruction
- Patients who are deemed equal surgical candidates for radial forearm free flap and ulnar forearm free flap reconstruction
- Preoperative Allen's test completed and passed
- Patients have the capacity to complete the informed consent process
Who cannot join
- Patients that are not candidates for a forearm flap based on their physiology
- Clinically evident peripheral neuropathy (e.g., diabetic neuropathy, leprosy)
- Patients requiring concurrent forearm bone for reconstruction
- Child, prisoner, or other vulnerable group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Functional Outcomes and Morbidity of the Radial Forearm Versus the Ulnar Forearm Free Flap: A Prospective, Randomized Trial
This study evaluates donor site outcomes in patients receiving radial forearm free flap reconstruction versus ulnar forearm free flap reconstruction. Patients who meet criteria for forearm free flap reconstruction are randomized to receiving either radial forearm free flap or ulnar forearm free flap reconstruction.
Read the detailed description
The radial forearm free flap and the ulnar forearm free flap are both well-described procedures used for free tissue transfer in reconstructive surgery. Although forearm free flaps are frequently performed, there is insufficient prospective data looking at the morbidity of the radial compared to ulnar forearm free flaps. The goal of this research study is to characterize the outcomes for each of these two flaps, and to determine if there is surgical equipoise, or if one flap is better than the other.
- Conditions
- Free Tissue Flaps
- Being tested
- Radial Forearm Free Flap, Ulnar Forearm Free Flap
- Keywords
- Radial Forearm Free Flap, Ulnar Forearm Free Flap, Free Tissue Transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Forearm Free FlapProcedure or surgery
Subjects in this arm will undergo a radial forearm free flap.
Ulnar Forearm Free FlapProcedure or surgery
Subjects in this arm will undergo an ulnar forearm free flap.
| Study group | Role | What they receive |
|---|---|---|
| Radial forearm free flap | Active comparator | Subjects in this arm will receive a radial forearm free flap. Receives: Procedure: Radial Forearm Free Flap |
| Ulnar forearm free flap | Active comparator | Subjects in this arm will receive an ulnar forearm free flap. Receives: Procedure: Ulnar Forearm Free Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Grip Strength (lbs) in the operative hand and non-operative hand
Subjects' grip strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied by the hand to a Jamar Dynometer in pounds.
Measured: up to 6 months
Average Key Pinch Strength (lbs) in the operative hand and non-operative hand
Subjects' pinch strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied with key pinch in pounds.
Measured: up to 6 months
Average Physician and Patient Rating of Scar Appearance
Subject's and physician's reported assessment of scar appearance on a Likert scale up to 10.
Measured: up to 6 months
Aggregated Brief Michigan Hand Questionnaire results (composite score)
Subjects' reported outcomes of hand function, as measured by the brief Michigan Hand Questionnaire survey results, on a scale up to 100.
Measured: up to 6 months
Average Static Two Point Discrimination (mm)
Subjects' static two point discrimination threshold in their finger pads, palm, and dorsum of the hand, in the operative and non-operative extremity, each measured in millimeters.
Measured: up to 6 months
Secondary outcomes (12)
Number of patients with complete flap loss
Number of patients with complete flap loss as assessed by chart review.
Measured: up to 6 months
Number of patients with partial flap loss
Number of patients with partial flap loss as assessed by chart review.
Measured: up to 6 months
Number of patients reporting cold intolerance
Number of patients reporting cold intolerance in the operative and non-operative extremity as assessed by patient's response to questioning them about feeling cold intolerance.
Measured: up to 6 months
Number of patients reporting neuropathy
Number of patients reporting cold intolerance as assessed by patient's response to questioning them about feeling neuropathy
Measured: up to 6 months
Number of patients with postoperative hematoma at donor site
Number of patients with postoperative hematoma at donor site, as assessed by chart review.
Measured: up to 6 months
Number of patients with postoperative cellulitis at donor site
Number of patients with postoperative cellulitis at donor site as assessed by chart review.
Measured: up to 6 months
Number of patients with postoperative hematoma at recipient site
Number of patient with postoperative hematoma at recipient site, as assessed by chart review
Measured: up to 6 months
Number of patient with postoperative infection at recipient site
Number of patient with postoperative infection at recipient site, as assessed by chart review.
Measured: up to 6 months
Number of patients experiencing mortality
Number of patients experiencing mortality, as assessed by chart review.
Measured: up to 6 months
Number of patients with donor site dehiscence
Number of patients with donor site dehiscence, as assessed by chart review
Measured: up to 6 months
Number of patients with partial skin graft non-take
Number of patients with partial skin graft non-take, as assessed by chart review
Measured: up to 6 months
Number of patients with complete skin graft non-take
Number of patients with complete skin graft non-take, as assessed by chart review
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Jan 2018
- Primary completion15 Jul 2023
- Study completion15 Aug 2023
Why it stopped: inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Tissue FlapsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects are assigned to one of two treatment arms
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Adkinson, Indiana University
- Investigators
- Joshua Adkinson, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579277
- Sponsor's protocol ID
- 1712593520
- Status last verified
- Aug 2023
- First submitted
- 24 Jan 2018
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functional Outcomes and Morbidity of the Radial Forearm Versus the Ulnar Forearm Free Flap: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT03579277
- Acronym / sponsor ID
- 1712593520
- Conditions
- Free Tissue Flaps
- Keywords
- Radial Forearm Free Flap, Ulnar Forearm Free Flap, Free Tissue Transfer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequate enrollment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates donor site outcomes in patients receiving radial forearm free flap reconstruction versus ulnar forearm free flap reconstruction. Patients who meet criteria for forearm free flap reconstruction are randomized to receiving either radial forearm free flap or ulnar forearm free flap reconstruction.
Detailed description
The radial forearm free flap and the ulnar forearm free flap are both well-described procedures used for free tissue transfer in reconstructive surgery. Although forearm free flaps are frequently performed, there is insufficient prospective data looking at the morbidity of the radial compared to ulnar forearm free flaps. The goal of this research study is to characterize the outcomes for each of these two flaps, and to determine if there is surgical equipoise, or if one flap is better than the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Subjects are assigned to one of two treatment arms
| Arm | Type | Receives |
|---|---|---|
| Radial forearm free flap | Active comparator | Procedure: Radial Forearm Free FlapSubjects in this arm will receive a radial forearm free flap. |
| Ulnar forearm free flap | Active comparator | Procedure: Ulnar Forearm Free FlapSubjects in this arm will receive an ulnar forearm free flap. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with planned forearm free flap reconstruction
- Patients who are deemed equal surgical candidates for radial forearm free flap and ulnar forearm free flap reconstruction
- Preoperative Allen's test completed and passed
- Patients have the capacity to complete the informed consent process
Key exclusion criteria (4 listed)
- Patients that are not candidates for a forearm flap based on their physiology
- Clinically evident peripheral neuropathy (e.g., diabetic neuropathy, leprosy)
- Patients requiring concurrent forearm bone for reconstruction
- Child, prisoner, or other vulnerable group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial Forearm Free FlapSubjects in this arm will undergo a radial forearm free flap. | Procedure or surgery | Radial forearm free flap |
| Ulnar Forearm Free FlapSubjects in this arm will undergo an ulnar forearm free flap. | Procedure or surgery | Ulnar forearm free flap |
Primary outcome
Average Grip Strength (lbs) in the operative hand and non-operative hand
Time frame: up to 6 months
Subjects' grip strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied by the hand to a Jamar Dynometer in pounds.
Average Key Pinch Strength (lbs) in the operative hand and non-operative hand
Time frame: up to 6 months
Subjects' pinch strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied with key pinch in pounds.
Average Physician and Patient Rating of Scar Appearance
Time frame: up to 6 months
Subject's and physician's reported assessment of scar appearance on a Likert scale up to 10.
Aggregated Brief Michigan Hand Questionnaire results (composite score)
Time frame: up to 6 months
Subjects' reported outcomes of hand function, as measured by the brief Michigan Hand Questionnaire survey results, on a scale up to 100.
Average Static Two Point Discrimination (mm)
Time frame: up to 6 months
Subjects' static two point discrimination threshold in their finger pads, palm, and dorsum of the hand, in the operative and non-operative extremity, each measured in millimeters.
12 secondary outcomes
Number of patients with complete flap loss
Time frame: up to 6 months
Number of patients with partial flap loss
Time frame: up to 6 months
Number of patients reporting cold intolerance
Time frame: up to 6 months
Number of patients reporting neuropathy
Time frame: up to 6 months
Number of patients with postoperative hematoma at donor site
Time frame: up to 6 months
Number of patients with postoperative cellulitis at donor site
Time frame: up to 6 months
Number of patients with postoperative hematoma at recipient site
Time frame: up to 6 months
Number of patient with postoperative infection at recipient site
Time frame: up to 6 months
Number of patients experiencing mortality
Time frame: up to 6 months
Number of patients with donor site dehiscence
Time frame: up to 6 months
Number of patients with partial skin graft non-take
Time frame: up to 6 months
Number of patients with complete skin graft non-take
Time frame: up to 6 months
Results and safety
The study was stopped early (reason given: inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Adkinson, M.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Forearm Free Flap and Ulnar Forearm Free Flap in people with Free Tissue Flaps, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inadequate enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Grip Strength (lbs) in the operative hand and non-operative hand (time frame: up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.