Efficacy of Application of Myriad Matrix to Split Thickne... | NCT06647394

Studies
Efficacy of Application of Myriad Matrix to Split Thickness Skin Graft Sites

NCT06647394

Sponsor

University of Alabama at Birmingham

Status

Withdrawn

Last Update Posted

May 25, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Skin Grafts

Interventions

Matrix Dressing

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UAB	Other Identifier	UAB

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study never opened or enrolled any subjects.

Expanded Access Info

Start Date

Mar 2025Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Feb 2028Estimated

First Submitted Date

Oct 16, 2024

First Submission Date that Met QC Criteria

Oct 16, 2024

First Posted Date

Oct 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2025

Last Update Posted Date

May 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Benjamin Greene, Associate Professor, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Matrix Dressing	Procedure	extracellular matrix dressing soaked in 4% topical lidocaine to the skin graft donor site

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Improvement	patients will rate pain level at donor site	48 hours, 2 weeks, 4-6 weeks post operative visit
Wound Healing	Patients will rate appearance of would using the scar-Q questionnaire	2 weeks and 4-6 weeks post operative visit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 and over who are undergoing a split thickness skin graft at UAB.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients undergoing a split thickness skin graft

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided