Head and Neck NeoplasmsNCT03875833
Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest
A study testing Collagen Nerve Wrap Conduit in people with Head and Neck Neoplasms and Dysesthesia, run by The University of Texas Health Science Center, Houston.
Trial summary
The purpose of this study is to determine whether collagen nerve conduits placed on exposed radial and ulnar nerves during radial and ulnar forearm free flap harvests will reduce the occurrence and degree of sensory nerve deficit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Dysesthesia
- What is being tested?
- Collagen Nerve Wrap Conduit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2020to 1 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients present with a complex defect after tumor resection
- all these cases done with the departments of Oral and Maxillofacial Surgery and Otolaryngology at the University of Texas in multiple locations that include, Memorial Hermann Hospital, Ben Taub General Hospital, Lyndon B. Johnson General Hospital and The Methodist hospital.
- patients that have been diagnosed with head and neck tumors and who will undergo a composite resection and reconstruction with radial or ulnar free vascularized flap.
Who cannot join
- pre-existing nerve deficits
- pregnant women
About this study
The purpose of this study is to determine whether collagen nerve conduits placed on exposed radial and ulnar nerves during radial and ulnar forearm free flap harvests will reduce the occurrence and degree of sensory nerve deficit.
- Conditions
- Head and Neck Neoplasms, Dysesthesia
- Being tested
- Collagen Nerve Wrap Conduit
- Medical subject headings
- Head and Neck Neoplasms, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen Nerve Wrap ConduitDevice
The collagen nerve wrap conduit will be placed on all exposed radial and ulnar nerves at the time of free flap harvest.
| Study group | Role | What they receive |
|---|---|---|
| Collagen Nerve Wrap Conduit | Experimental | Not described Receives: Device: Collagen Nerve Wrap Conduit |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function
Measured: baseline
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function
Measured: 3 months
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function
Measured: 6 months
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function
Measured: 12 months
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
Measured: baseline
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
Measured: 3 months
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
Measured: 6 months
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start9 Oct 2020
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James C Melville, The University of Texas Health Science Center, Houston
- Investigators
- James C Melville, DDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875833
- Sponsor's protocol ID
- HSC-DB-18-0760
- Status last verified
- May 2023
- First submitted
- 13 Mar 2019
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest
- ClinicalTrials.gov ID
- NCT03875833
- Acronym / sponsor ID
- HSC-DB-18-0760
- Conditions
- Head and Neck Neoplasms, Dysesthesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 15 Mar 2019 (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.
The purpose of this study is to determine whether collagen nerve conduits placed on exposed radial and ulnar nerves during radial and ulnar forearm free flap harvests will reduce the occurrence and degree of sensory nerve deficit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen Nerve Wrap Conduit | Experimental | Device: Collagen Nerve Wrap Conduit |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients present with a complex defect after tumor resection
- all these cases done with the departments of Oral and Maxillofacial Surgery and Otolaryngology at the University of Texas in multiple locations that include, Memorial Hermann Hospital, Ben Taub General Hospital, Lyndon B. Johnson General Hospital and The Methodist hospital.
- patients that have been diagnosed with head and neck tumors and who will undergo a composite resection and reconstruction with radial or ulnar free vascularized flap.
Key exclusion criteria (2 listed)
- pre-existing nerve deficits
- pregnant women
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 |
|---|---|---|
| Collagen Nerve Wrap ConduitThe collagen nerve wrap conduit will be placed on all exposed radial and ulnar nerves at the time of free flap harvest. | Device | Collagen Nerve Wrap Conduit |
Primary outcome
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function
Time frame: baseline
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function
Time frame: 3 months
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function
Time frame: 6 months
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function
Time frame: 12 months
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
Time frame: baseline
Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
Time frame: 3 months
Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
Time frame: 6 months
Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
Time frame: 12 months
Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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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.
James C Melville, DDS principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A study testing Collagen Nerve Wrap Conduit in people with Head and Neck Neoplasms and Dysesthesia, run by The University of Texas Health Science Center, Houston.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function (time frame: baseline). The study lists 8 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 22 May 2023.