Microsurfaced Grafts in Deep Burn Wounds

NCT04589442 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: MB2019-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Wound Heal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Infection

  Through 12 months

• Autograft take

  2 weeks

• Tissue oxygenation

  2 weeks

• Tissue Oxygenation

  6 weeks

• Scar assessment

  3, 6, 9, 12 months

Study Arms (2)

Standard of Care Dermal Graft

ACTIVE COMPARATOR

Standard of care cryopreserved cadaveric split thickness skin grafts

Biological: Split thickness skin graft

Standard of Care Dermal Graft - Microsurfaced

EXPERIMENTAL

Microsurfaced cryopreserved cadaveric split thickness skin grafts

Biological: microsurfaced split thickness skin graft

Interventions

Split thickness skin graft BIOLOGICAL

standard of care graft

Standard of Care Dermal Graft

microsurfaced split thickness skin graft BIOLOGICAL

standard of care graft that has been microsurfaced

Standard of Care Dermal Graft - Microsurfaced

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• CellTherX: lead

Study Sites (1)

Joseph M Still Research Foundation

Augusta, Georgia, 30909, United States

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Claus Brandigi, MD

  Joseph M Still Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Wilson

CONTACT

706-364-2966; joan.wilson@jmsreserachfoundation.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 19, 2020
• Study Start: January 4, 2021
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)