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

53 participantsStarted 2023-01-01

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Percentage of donor site wound closure

Timeframe: Day 14 post-op

Trial details

NCT IDNCT05439746

SponsorImbed Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-30

View on ClinicalTrials.gov More Wounds and Injuries trials