Microsurfaced Grafts in Deep Burn Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Burns Wound Heal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard of Care Dermal Graft

Standard of care cryopreserved cadaveric split thickness skin grafts

Group Type ACTIVE_COMPARATOR

Split thickness skin graft

Intervention Type BIOLOGICAL

standard of care graft

Standard of Care Dermal Graft - Microsurfaced

Microsurfaced cryopreserved cadaveric split thickness skin grafts

Group Type EXPERIMENTAL

microsurfaced split thickness skin graft

Intervention Type BIOLOGICAL

standard of care graft that has been microsurfaced

Interventions

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Split thickness skin graft

standard of care graft

Intervention Type BIOLOGICAL

microsurfaced split thickness skin graft

standard of care graft that has been microsurfaced

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No