Status:
UNKNOWN
A Study to Evaluate the Efficacy of Microlyte Matrix in the Management of Donor Site Wounds
Lead Sponsor:
Imbed Biosciences
Collaborating Sponsors:
Arizona Burn Center, Maricopa Medical Center (Phoenix, AZ)
Conditions:
Wounds and Injuries
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Detailed Description
The proposed study is a randomized, controlled, open-label clinical trial to assess the efficacy in wound healing of the FDA 510k cleared Microlyte® Matrix (K153756) in surgically created partial thic...
Eligibility Criteria
Inclusion
- Adult patients where creation of a donor site wound for any indication including chronic wound, burn wound, surgical/traumatic wound, and tumor excision.
- Donor site wound with a surface area of greater than 100 cm2 is required.
- At least 18 years of age
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Ability and willingness to adhere to the study intervention regimen and follow-up visits
Exclusion
- Age less than 18 years.
- Vulnerable population.
- Pregnant, lactating or nursing women.
- Unable to provide consent.
- Presumed unable to complete follow-up assessments.
- Prior adverse reaction or sensitivity to silver.
- Enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study.
- Presumed impairment of wound healing as with prescription drugs or medical diagnoses that have potential to impair wound healing at the discretion of clinical investigator, e.g., cancer, transplant status, autoimmune disease, severe malnutrition, etc.
- Any diagnosis with concern for 30 Day mortality.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05439746
Start Date
January 1 2023
End Date
January 30 2024
Last Update
October 28 2022
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