A Study to Evaluate the Efficacy of Microlyte Matrix in the Management of Donor Site Wounds
Primary Purpose
Wounds and Injuries
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microlyte® Matrix
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries focused on measuring Donor, Skin Graft, Wound, Partial Thickness
Eligibility Criteria
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.
- Any diagnosis with concern for 30 Day mortality.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Matrix Comparison
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of donor site wound closure
Signs of infection or allergic reactions, pain, and pruritus assessed during each study visit.
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
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.
Signs of infection or allergic reactions, pain, and pruritus
Full Information
NCT ID
NCT05439746
First Posted
June 1, 2022
Last Updated
October 27, 2022
Sponsor
Imbed Biosciences
Collaborators
Arizona Burn Center, Maricopa Medical Center (Phoenix, AZ)
1. Study Identification
Unique Protocol Identification Number
NCT05439746
Brief Title
A Study to Evaluate the Efficacy of Microlyte Matrix in the Management of Donor Site Wounds
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imbed Biosciences
Collaborators
Arizona Burn Center, Maricopa Medical Center (Phoenix, AZ)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
Keywords
Donor, Skin Graft, Wound, Partial Thickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
53 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Matrix Comparison
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Microlyte® Matrix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of donor site wound closure
Description
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.
Time Frame
Day 14 post-op
Secondary Outcome Measure Information:
Title
Percentage of donor site wound closure
Description
Signs of infection or allergic reactions, pain, and pruritus assessed during each study visit.
Time Frame
Day 7 post-op
Title
Durability of wound closure, assessed by percentage of wound closure
Description
Wound Closure ranges from 0%-100% with 0% being no wound closure occurring and 100% being full closure
Time Frame
12 weeks
Title
Pain, itching, and scarring, assessed by patients using the Patient and Observer Scar Assessment Scale (POSAS).
Description
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.
Time Frame
12 weeks
Title
Signs of infection or allergic reactions, pain, and pruritus
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Any diagnosis with concern for 30 Day mortality.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy of Microlyte Matrix in the Management of Donor Site Wounds
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