A Study to Evaluate the Efficacy of Microlyte Matrix in the Management of Donor Site Wounds (NCT05439746) | Clinical Trial Compass
UnknownNot Applicable
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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing something called Microlyte Matrix for donor site wounds — can you explain what Microlyte Matrix is and how it's different from the standard dressings you'd normally use on a donor site wound?
2The trial's recruitment status is listed as unknown, which makes me uncertain whether it's still enrolling — do you know if this study is currently active and accepting patients, and how would that affect my options?
3The main thing this trial is measuring is the percentage of wound closure at the donor site — what does that mean in practice, and how does that outcome compare to what we'd expect with conventional wound care?
4Since this trial is listed as Phase NA, it's not a typical phase 1, 2, or 3 drug study — can you help me understand what level of evidence already exists for this product and what that means for how confident we can be about its safety and effectiveness?
5Given that donor site wounds are a known complication of skin graft procedures, would you recommend I consider standard wound care first, or is there a reason this trial might be worth discussing as part of my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.