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

Clinical Trial to Assess the Efficacy of Microlyte Matrix on the Healing of Surgically Created Partial Thickness Donor Site Wounds on Patients Requiring Split-thickness Skin Grafting

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: Microlyte® Matrix

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 thickness donor site wounds > 100 cm2 in size on patients and harvested at 12/1000th inch requiring split-thickness skin grafting. Subjects are expected to be hospitalized as in-patients for approximately 7 days following initial donor site surgery. Study visits conducted after hospital discharge must be conducted as out-patient clinic visits.

Each wound will be divided into proximal and distal halves with one half randomized to receive Microlyte® Matrix. Kaltostat/Tegaderm will be used as the control. Thus, each patient is their own control removing the potential variability of the depth of donor site wounds between patients as a confounding factor.

Microlyte® Matrix is a FDA-cleared (K153756) antimicrobial dressing manufactured by Imbed Biosciences, Inc. (Madison, WI), which is an ISO 13485 certified/FDA QSR compliant facility. It is indicated for the management of partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic foot ulcers, first and second-degree burns, abrasions and lacerations, donor sites and surgical wounds.

• Study Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patients where creation of a donor site wound for any indication including chronic wound, burn wound, surgical/traumatic wound, and tumor excision.
2. Donor site wound with a surface area of greater than 100 cm2 is required.
3. At least 18 years of age
4. Provision of signed and dated informed consent form
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Ability and willingness to adhere to the study intervention regimen and follow-up visits

Exclusion Criteria:

1. Age less than 18 years.
2. Vulnerable population.
3. Pregnant, lactating or nursing women.
4. Unable to provide consent.
5. Presumed unable to complete follow-up assessments.
6. Prior adverse reaction or sensitivity to silver.
7. Enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study.
8. 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.
9. Any diagnosis with concern for 30 Day mortality.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Matrix Comparison; Qualified subjects are randomly assigned Microlyte Matrix in an open label fashion to half of a randomized similar depth donor site areas within a subject and determining percent healing at Day 14.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of donor site wound closure	Therefore, assessment of the percentage wound closure at the time of primary outcome assessment (14 days) provides a very reliable method for detection of differences between groups. Digital photography and Image-J analysis allow for blinded assessment of primary outcome.	Day 14 post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of donor site wound closure	Signs of infection or allergic reactions, pain, and pruritus assessed during each study visit.	Day 7 post-op
Durability of wound closure, assessed by percentage of wound closure	Wound Closure ranges from 0%-100% with 0% being no wound closure occurring and 100% being full closure	12 weeks
Pain, itching, and scarring, assessed by patients using the Patient and Observer Scar Assessment Scale (POSAS).	POSAS Scale is a series of questions with answers ranging from 1-10, with 1 dictating few or negligible differences from normal skin, and 10 being unimaginable scar difference from normal skin.	12 weeks
Signs of infection or allergic reactions, pain, and pruritus		12 weeks

Collaborators and Investigators

• Sponsor: Imbed Biosciences
• Collaborators: Arizona Burn Center, Maricopa Medical Center (Phoenix, AZ)

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2023
• Primary Completion (ANTICIPATED): January 30, 2024
• Study Completion (ANTICIPATED): January 30, 2024

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (ACTUAL): June 30, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Wound; Skin Graft; Donor; Partial Thickness
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Imbed 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes