NCT07558096Not yet recruiting
Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest
A Randomized Controlled Pilot Study Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
Radial forearm free flap (RFFF) reconstruction is commonly used for head and neck defects but is associated with donor-site morbidity, including neuropathic pain and sensory disturbance. This randomized controlled pilot study evaluates whether placement of a soft tissue matrix over the superficial radial nerve at the donor site reduces neuropathic pain and improves sensory outcomes compared to standard closure alone.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 23 Apr 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Head and neck cancer
- NCT number
- NCT07558096
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Nov 2026 to the primary completion date, Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior ipsilateral forearm surgery affecting nerve anatomy
Other illness
- Active donor-site infection
- Severe peripheral vascular disease
Other
- Reconstruction using a non-RFFF free flap
- Pre-existing ipsilateral radial nerve neuropathy
- Inability to complete follow-up
Who the study is looking for
- Age ≥ 18 years
- Undergoing RFFF for head and neck reconstruction
- Treated at University of Alabama at Birmingham
- Able to provide informed consent
- Willing to comply with follow-up
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.