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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

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring Donor, Skin Graft, Wound, Partial Thickness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

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

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

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

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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