Microsurfaced Grafts in Deep Burn Wounds

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

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.

Study Overview

• Status: Unknown
• Conditions: Burns; Wound Heal
• Intervention / Treatment: Biological: Split thickness skin graft; Biological: microsurfaced split thickness skin graft

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Recruiting
      • JOSEPH M STILL RESEARCH FOUNDATION
      • Contact: Joan Wilson; Phone Number: 706-364-2966; Email: joan.wilson@jmsresearchfoundation.org
      • Principal Investigator: Claus Brandigi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care Dermal Graft; Standard of care cryopreserved cadaveric split thickness skin grafts	Biological: Split thickness skin graft; standard of care graft
Experimental: Standard of Care Dermal Graft - Microsurfaced; Microsurfaced cryopreserved cadaveric split thickness skin grafts	Biological: microsurfaced split thickness skin graft; standard of care graft that has been microsurfaced

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection	Incidence of Infection at each treatment study visit	Through 12 months
Autograft take	Autograft take will be documented as a percentage of the graft by the physician	2 weeks
Tissue oxygenation	Tissue oxygenation will be assessed using hyperspectral imaging	2 weeks
Tissue Oxygenation	Change in tissue oxygenation at study burn site at the time of autografting as compared to baseline.	6 weeks
Scar assessment	Scar will be assessed using the Patient and Observer Scar Assessment Scale (POSAS)	3, 6, 9, 12 months
Tissue oxygenation	Tissue oxygenation will be assessed using hyperspectral imaging	3, 6, 9, 12 months

Collaborators and Investigators

• Sponsor: Markman Biologics Corporation
• Investigators: Principal Investigator: Claus Brandigi, MD, JOSEPH M STILL RESEARCH FOUNDATION

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: MB2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No