MedTrace Logo

A Study to Evaluate the Efficacy of Microlyte Matrix in the Management of Donor Site Wounds

NCT05439746 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-10-28

No results posted yet for this study

Summary

A study to to evaluate the efficacy of Microlyte® Matrix by demonstrating its superiority to the standard of care in the healing of donor site wounds in patients requiring split-thickness grafting, as well as to assess the occurrence of donor site wound infection, allergic reaction, pain and itching, and scarring at 12 weeks, assessed by patients using the Patient and Observer Scar Assessment Scale (POSAS).

Conditions

  • Wounds and Injuries

Interventions

DEVICE

Microlyte® Matrix

Microlyte® Matrix is indicated for the management of wounds and can be used over-the-counter for minor wounds such as abrasions and lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional, Microlyte® Matrix may be used for more serious wounds such as partial and full thickness pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, abrasions and lacerations, donor sites and surgical wounds. Microlyte® Matrix may be used over debrided and grafted partial thickness wounds.

Sponsors & Collaborators

  • Arizona Burn Center, Maricopa Medical Center (Phoenix, AZ)

    collaborator UNKNOWN

  • Imbed Biosciences

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-01-30
Completion
2024-01-30
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05439746 on ClinicalTrials.gov