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Microsurfaced Grafts for Deep Burn Wounds

This study is looking at how well a special type of skin graft, called a microsurfaced split thickness skin graft, works compared to a standard split thickness skin graft for treating deep burns. Both types of grafts are taken from donated skin (cadaveric grafts). Researchers want to see if the microsurfaced graft helps burn wounds heal better and faster. You might be able to join if you are at least 21 years old and have a deep partial or full thickness burn from a flame, scald, or contact. The study will measure how quickly your wound prepares for healing over 6 weeks. The current status of this study is unclear, and it plans to enroll 20 participants.

Study design
This is a randomized study where participants receive both the standard and microsurfaced grafts on different parts of their burn wounds. It is designed to compare the two types of grafts within the same person.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track wound bed preparation for up to 6 weeks. It will also look at long-term scar outcomes, but the duration is not specified.

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NCT04589442

Microsurfaced Grafts in Deep Burn Wounds

Recruiting
PHASE4Ages 21+InterventionalTreatment
CellTherX
~20 participants
Updated 2021-01-15 on ClinicalTrials.gov
What's tested:Split thickness skin graftmicrosurfaced split thickness skin graft

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Wound bed prep
Measured over 6 week

Conditions

Burns
Wound Heal

Explore related trials

Burn

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Claus Brandigi, MD · PRINCIPAL_INVESTIGATOR · Joseph M Still Research Foundation

Who to contact

Joan Wilson
[email protected]
706-364-2966
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Wound bed prep6 week

    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.