Clinical trial NCT04589442: Microsurfaced Grafts in Deep Burn Wounds
Official title: A Prospective, Randomized Study to Evaluate the Effectiveness of Microsurfaced vs Control Cadaveric Decellularized Grafts to Establish Wound Bed Preparedness in Deep Partial and Full Thickness Burn Wounds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Burns
Wound Heal
Lead sponsor: CellTherX
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Wound bed prep
timeFrame: 6 week
Secondary outcomes:
measure: Infection
timeFrame: Through 12 months
measure: Autograft take
timeFrame: 2 weeks
measure: Tissue oxygenation
timeFrame: 2 weeks
measure: Tissue Oxygenation
timeFrame: 6 weeks
measure: Scar assessment
timeFrame: 3, 6, 9, 12 months
measure: Tissue oxygenation
timeFrame: 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Joseph M Still Research Foundation
state: Georgia
Study officials:
affiliation: Joseph M Still Research Foundation
name: Claus Brandigi, MD
role: PRINCIPAL_INVESTIGATOR
References: