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Microsurfaced Grafts in Deep Burn Wounds

Primary Purpose

Burns, Wound Heal

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Split thickness skin graft

microsurfaced split thickness skin graft

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent by patient or Legally Authorized Representative (LAR)
Subject with deep partial or full thickness burn injury due to flame burn, scald injury or contact burn
Study burn site large enough to accommodate placement of control and microsurfaced cadaveric graft (minimum 4 cm2 each) at the same location OR 2 study burn sites large enough to each accommodate control and microsurfaced cadaveric graft, respectively at minimum 4 cm2.
Total Body Surface Area burned (TBSA) total ≤30 %
Admission within 72 hours of burn injury
Non-infected wound as diagnosed by the attending physician upon admission
Treated as an outpatient or in an observational setting
21 years of age or older

Exclusion Criteria:

Burns involving the face
Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
Admission time greater than 72 hours after the injury
Wounds noted to be infected at admission
Is pregnant or plans to become pregnant
Is nursing or actively lactating
Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's participation in the study protocol or record study materials
Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study

Sites / Locations

Joseph M Still Research FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care Dermal Graft

Standard of Care Dermal Graft - Microsurfaced

Arm Description

Standard of care cryopreserved cadaveric split thickness skin grafts

Microsurfaced cryopreserved cadaveric split thickness skin grafts

Outcomes

Primary Outcome Measures

Wound bed prep

To compare wound bed preparedness/time to autograft in deep-partial and full thickness burns and burn wound healing in partial thickness burns in burn sites treated with Microsurfaced vs Control cadaveric graft-treated groups through 6 weeks post initial injury.

Secondary Outcome Measures

Infection

Incidence of Infection at each treatment study visit

Autograft take

Autograft take will be documented as a percentage of the graft by the physician

Tissue oxygenation

Tissue oxygenation will be assessed using hyperspectral imaging

Tissue Oxygenation

Change in tissue oxygenation at study burn site at the time of autografting as compared to baseline.

Scar assessment

Scar will be assessed using the Patient and Observer Scar Assessment Scale (POSAS)

Tissue oxygenation

Tissue oxygenation will be assessed using hyperspectral imaging

Full Information

NCT ID

NCT04589442

First Posted

October 5, 2020

Last Updated

January 13, 2021

Sponsor

Markman Biologics Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04589442

Brief Title

Microsurfaced Grafts in Deep Burn Wounds

Official Title

A Prospective, Randomized Study to Evaluate the Effectiveness of Microsurfaced vs Control Cadaveric Decellularized Grafts to Establish Wound Bed Preparedness in Deep Partial and Full Thickness Burn Wounds

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 4, 2021 (Actual)

Primary Completion Date

August 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Markman Biologics Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to wound bed preparedness through 6 weeks (Part A) and wound site healing, graft take and long-term scar outcomes (Part B). Subjects will be treated with both control and microsurfaced cadaveric grafts on adjacent deep-partial or full-thickness burn wounds.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns, Wound Heal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care Dermal Graft

Arm Type

Active Comparator

Arm Description

Standard of care cryopreserved cadaveric split thickness skin grafts

Arm Title

Standard of Care Dermal Graft - Microsurfaced

Arm Type

Experimental

Arm Description

Microsurfaced cryopreserved cadaveric split thickness skin grafts

Intervention Type

Biological

Intervention Name(s)

Split thickness skin graft

Intervention Description

standard of care graft

Intervention Type

Biological

Intervention Name(s)

microsurfaced split thickness skin graft

Intervention Description

standard of care graft that has been microsurfaced

Primary Outcome Measure Information:

Title

Wound bed prep

Description

Time Frame

6 week

Secondary Outcome Measure Information:

Title

Infection

Description

Incidence of Infection at each treatment study visit

Time Frame

Through 12 months

Title

Autograft take

Description

Autograft take will be documented as a percentage of the graft by the physician

Time Frame

2 weeks

Title

Tissue oxygenation

Description

Tissue oxygenation will be assessed using hyperspectral imaging

Time Frame

2 weeks

Title

Tissue Oxygenation

Description

Change in tissue oxygenation at study burn site at the time of autografting as compared to baseline.

Time Frame

6 weeks

Title

Scar assessment

Description

Scar will be assessed using the Patient and Observer Scar Assessment Scale (POSAS)

Time Frame

3, 6, 9, 12 months

Title

Tissue oxygenation

Description

Tissue oxygenation will be assessed using hyperspectral imaging

Time Frame

3, 6, 9, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent by patient or Legally Authorized Representative (LAR) Subject with deep partial or full thickness burn injury due to flame burn, scald injury or contact burn Study burn site large enough to accommodate placement of control and microsurfaced cadaveric graft (minimum 4 cm2 each) at the same location OR 2 study burn sites large enough to each accommodate control and microsurfaced cadaveric graft, respectively at minimum 4 cm2. Total Body Surface Area burned (TBSA) total ≤30 % Admission within 72 hours of burn injury Non-infected wound as diagnosed by the attending physician upon admission Treated as an outpatient or in an observational setting 21 years of age or older Exclusion Criteria: Burns involving the face Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite) Admission time greater than 72 hours after the injury Wounds noted to be infected at admission Is pregnant or plans to become pregnant Is nursing or actively lactating Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years. Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's participation in the study protocol or record study materials Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joan Wilson

Phone

706-364-2966

joan.wilson@jmsreserachfoundation.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claus Brandigi, MD

Organizational Affiliation

Joseph M Still Research Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Joseph M Still Research Foundation

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joan Wilson

Phone

706-364-2966

joan.wilson@jmsresearchfoundation.org

First Name & Middle Initial & Last Name & Degree

Claus Brandigi, MD

12. IPD Sharing Statement

Plan to Share IPD

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Microsurfaced Grafts in Deep Burn Wounds

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