Microsurfaced Grafts in Deep Burn Wounds

CellTherX

Status and phase: Unknown; Phase 4

Conditions: Wound Heal; Burns

Treatments: Biological: Split thickness skin graft; Biological: microsurfaced split thickness skin graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT04589442

MB2019-01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Standard of Care Dermal Graft

Active Comparator group

Description:

Standard of care cryopreserved cadaveric split thickness skin grafts

Treatment:

Biological: Split thickness skin graft

Standard of Care Dermal Graft - Microsurfaced

Experimental group

Description:

Microsurfaced cryopreserved cadaveric split thickness skin grafts

Treatment:

Biological: microsurfaced split thickness skin graft