Wounds and InjuriesNCT05439746
A Study to Evaluate the Efficacy of Microlyte Matrix in the Management of Donor Site Wounds
A study testing Microlyte® Matrix in people with Wounds and Injuries, run by Imbed Biosciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Microlyte® Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
Official title: 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).
Read the 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.
- Conditions
- Wounds and Injuries
- Being tested
- Microlyte® Matrix
- Keywords
- Donor, Skin Graft, Wound, Partial Thickness
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microlyte® MatrixDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Microlyte® Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14 post-op
Secondary outcomes (4)
Percentage of donor site wound closure
Signs of infection or allergic reactions, pain, and pruritus assessed during each study visit.
Measured: 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
Measured: 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.
Measured: 12 weeks
Signs of infection or allergic reactions, pain, and pruritus
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imbed Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arizona Burn Center, Maricopa Medical Center (Phoenix, AZ)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439746
- Sponsor's protocol ID
- Imbed 01
- Status last verified
- Oct 2022
- First submitted
- 1 Jun 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05439746
- Acronym / sponsor ID
- Imbed 01
- Conditions
- Wounds and Injuries
- Keywords
- Donor, Skin Graft, Wound, Partial Thickness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Imbed BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Arizona Burn Center, Maricopa Medical Center (Phoenix, AZ)
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Matrix Comparison | Experimental | Device: Microlyte® MatrixQualified 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Age less than 18 years.
- Vulnerable population.
- Pregnant, lactating or nursing women.
- Unable to provide consent.
- Presumed unable to complete follow-up assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microlyte® MatrixMicrolyte® 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. | Device | Matrix Comparison |
Primary outcome
Percentage of donor site wound closure
Time frame: Day 14 post-op
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.
4 secondary outcomes
Percentage of donor site wound closure
Time frame: Day 7 post-op
Durability of wound closure, assessed by percentage of wound closure
Time frame: 12 weeks
Pain, itching, and scarring, assessed by patients using the Patient and Observer Scar Assessment Scale (POSAS).
Time frame: 12 weeks
Signs of infection or allergic reactions, pain, and pruritus
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Microlyte® Matrix in people with Wounds and Injuries, run by Imbed Biosciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of donor site wound closure (time frame: Day 14 post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.