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

NCT05439746 | Unknown FDA Device

• 1 other identifier: Imbed 01
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

Donor; Skin Graft; Wound; Partial Thickness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of donor site wound closure

  Day 7 post-op

• Durability of wound closure, assessed by percentage of wound closure

  12 weeks

• Pain, itching, and scarring, assessed by patients using the Patient and Observer Scar Assessment Scale (POSAS).

  12 weeks

• Signs of infection or allergic reactions, pain, and pruritus

  12 weeks

Study Arms (1)

Matrix Comparison

EXPERIMENTAL

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

Interventions

Microlyte® Matrix DEVICE

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.

Matrix Comparison

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imbed Biosciences: lead
• Arizona Burn Center, Maricopa Medical Center (Phoenix, AZ): collaborator

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The primary outcome assessment in this trial will be assessed by digital photography of the wounds as assessed by study team members who are blinded to the randomization.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 30, 2022
• Study Start: January 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share