Recruiting

Microsurfaced Grafts

Sponsor:

CellTherX

Code:

NCT04589442

Conditions

Burns

Wound Heal

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Split thickness skin graft

microsurfaced split thickness skin graft

Study Details

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

Study ID

NCT04589442

Start date

Jan 4, 2021

Status verified date

Jan, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Aug, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Dermal Graft

Standard of care cryopreserved cadaveric split thickness skin grafts

experimental: Standard of Care Dermal Graft - Microsurfaced

Microsurfaced cryopreserved cadaveric split thickness skin grafts

Interventions

Split thickness skin graft

standard of care graft

microsurfaced split thickness skin graft

standard of care graft that has been microsurfaced

Primary outcome measure

  • Wound bed prep [ Time Frame: 6 week ]

Central Contacts and Locations

Central contacts

Joan Wilson

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

Locations

Joseph M Still Research Foundation

Recruiting

Augusta, Georgia, United States, 30909

Contacts

Joan Wilson

706-364-2966joan.wilson@jmsresearchfoundation.org

Principal Investigator:

Claus Brandigi, MD

More Information

Sponsor

CellTherX

Last update posted

Jan 15, 2021

Last verified

Jan, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CellTherX on 2021-01-15.