Microsurfaced Grafts in Deep Burn Wounds
CellTherX · NCT04589442
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 21+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 4
- Target enrollment
- 20
- US sites recruiting
- 1
- Study start
- January 4, 2021
- Record last updated
- January 15, 2021
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is 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.
Being studied: Split thickness skin graft; microsurfaced split thickness skin graft
Conditions: Burns; Wound Heal
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Joseph M Still Research Foundation
Augusta, GA 30909
Site contact: Joan Wilson · 706-364-2966 · joan.wilson@jmsresearchfoundation.org
Study contacts (from the official record)
- Joan Wilson · 706-364-2966 · joan.wilson@jmsreserachfoundation.org