Skin GraftsNCT06647394
Efficacy of Application of Myriad Matrix to Split Thickness Skin Graft Sites
An observational study of Skin Grafts, run by University of Alabama at Birmingham.
Trial summary
To determine if application of Myriad Matrix to split thickness skin graft donor sites improves post-operative pain and appearance of the wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Grafts
- What is being tested?
- Matrix Dressing
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Feb 2028
- Phase
- Observational
- 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
Study population: patients undergoing a split thickness skin graft
Who may be able to join
- Patients 18 and over who are undergoing a split thickness skin graft at UAB.
Who cannot join
- Patients who are not planned to undergo a split thickness skin graft or who are unable or do not plan to attend follow up appointments will not be included.
About this study
To determine if application of Myriad Matrix to split thickness skin graft donor sites improves post-operative pain and appearance of the wound.
Read the detailed description
In the head and neck practice at UAB, split thickness skin grafts are a commonly used procedure for simple reconstruction. The standard dressing for donor sites is a strip of vaseline gauze which remains on the site the wound dries, and the gauze eventually falls off. Post operative pain and poor wound healing is a well established complication of the donor site, and various methods have been studied in an attempt to reduce these complications for patients in the post operative period. (1, 2, 3)
Myriad matrix is an engineered extracellular matrix (Ovine Forestomach Matrix) used for soft issue repair in complex wounds. This has been sporadically used by some of the faculty members at UAB for split thickness skin graft donor site dressings with anectodal improvement in pain and healing, though this has not yet been studied to our knowledge.
- Conditions
- Skin Grafts
- Being tested
- Matrix Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix DressingProcedure or surgery
extracellular matrix dressing soaked in 4% topical lidocaine to the skin graft donor site
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Improvement
patients will rate pain level at donor site
Measured: 48 hours, 2 weeks, 4-6 weeks post operative visit
Wound Healing
Patients will rate appearance of would using the scar-Q questionnaire
Measured: 2 weeks and 4-6 weeks post operative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study startMar 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2028 (estimated)
Why it stopped: The study never opened or enrolled any subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin GraftsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Greene, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647394
- Sponsor's protocol ID
- IRB-300013305
- Other IDs
- UAB
- Status last verified
- May 2025
- First submitted
- 16 Oct 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Application of Myriad Matrix to Split Thickness Skin Graft Sites
- ClinicalTrials.gov ID
- NCT06647394
- Acronym / sponsor ID
- IRB-300013305
- Conditions
- Skin Grafts
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study never opened or enrolled any subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 17 Oct 2024 (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.
To determine if application of Myriad Matrix to split thickness skin graft donor sites improves post-operative pain and appearance of the wound.
Detailed description
In the head and neck practice at UAB, split thickness skin grafts are a commonly used procedure for simple reconstruction. The standard dressing for donor sites is a strip of vaseline gauze which remains on the site the wound dries, and the gauze eventually falls off. Post operative pain and poor wound healing is a well established complication of the donor site, and various methods have been studied in an attempt to reduce these complications for patients in the post operative period. (1, 2, 3)
Myriad matrix is an engineered extracellular matrix (Ovine Forestomach Matrix) used for soft issue repair in complex wounds. This has been sporadically used by some of the faculty members at UAB for split thickness skin graft donor site dressings with anectodal improvement in pain and healing, though this has not yet been studied to our knowledge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing a split thickness skin graft
Key inclusion criteria (1 listed)
- Patients 18 and over who are undergoing a split thickness skin graft at UAB.
Key exclusion criteria (1 listed)
- Patients who are not planned to undergo a split thickness skin graft or who are unable or do not plan to attend follow up appointments will not be included.
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 |
|---|---|---|
| Matrix Dressingextracellular matrix dressing soaked in 4% topical lidocaine to the skin graft donor site | Procedure or surgery | – |
Primary outcome
Pain Improvement
Time frame: 48 hours, 2 weeks, 4-6 weeks post operative visit
patients will rate pain level at donor site
Wound Healing
Time frame: 2 weeks and 4-6 weeks post operative visit
Patients will rate appearance of would using the scar-Q questionnaire
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 25 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Grafts, run by University of Alabama at Birmingham.
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 1 inclusion and 1 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 25 May 2025. 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?
Pain Improvement (time frame: 48 hours, 2 weeks, 4-6 weeks post operative visit). The study lists 2 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 25 May 2025.