Partial Thickness Burn
Conditions
Keywords
thermal burn, burn
Brief summary
This study will evaluate the efficacy of a dehydrated human placental tissue product, commercially labeled as AmCoreMatrix Burn ™ versus SOC in the closure of partial thickness burns. Human Cellular and Tissue based Products (HCT/Ps), specifically Dehydrated Human Amnion - Intermediate Layer - Chorion Membrane (dHAICM) offer a multimodal biological approach to burn management. Unlike synthetic dressings or silver-based creams, dHAICM serves as a sophisticated bioactive scaffold. It is a minimally manipulated allograft that provides superior tensile strength and barrier function compared to single-layer membranes. This study aims to document its performance in hospital burn units.
Interventions
Dehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
PROCEDUREStandard of Care (SOC)
Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
Sponsors
Cellution Biologics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * One or more thermal burns classified as either superficial partial thickness or deep partial thickness. * Total Body Surface Area (TBSA) involvement between 5% and 15%. * Total burn index wound area is greater than 25 cm 2 and less than 0.25 m 2 (2500 cm 2 ) * 1 If 2 or more burns are present, each must have an area greater than 15 cm 2 * The participant must be willing and able to participate in the informed consent process.
Exclusion criteria
* Full thickness burns. * Burns present for \>72 hours prior to study evaluation * Burns requiring immediate autografting. * Superficial burns (1 st -degree) or burns not meeting criteria to be included in TBSA calculations. * Chemical or electrical burns. * Burns secondary to blast injury. * Burns causing vascular or respiratory compromise and burns requiring escharotomy * Any severe systemic comorbidities which could impair healing (e.g. active sepsis or major organ failure). * Known coagulopathy, platelet disorder, INR \> 1.6, PTT \> 38s, or platelets \< 50,000 per mm 3 * Uncontrolled diabetes. * Known life expectancy of \< 6 months. * Evidence of active infection in burn. * Target area for treatment includes the head, neck, palms of hands, soles of the feet, or genitals. * Viral infection which could impair healing or immune function (e.g. HIV, HBV, HCV) * Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception. * Currently requiring dialysis or planning to start within 6 months. * Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments. * Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit. * Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics. * Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Epithelialization | 1-10 weeks | Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Burn Area Change | 1-10 weeks | To evaluate the difference in percentage reduction in burn wound area at each follow-up visit in participants receiving dHAICM versus SOC alone. |
| Frequency of Full Epithelialization | 1-10 weeks | To compare the frequency of full epithelialization at 3 weeks in participants receiving dHAICM versus SOC alone. |
| Changes in Pain Scores Associated with Target Burns | 1-10 weeks | To determine the reduction in pain scores (VAS) for participants during dressing changes. |
| Changes in Scarring Quality of Target Burn | 1-10 weeks | To determine the difference in assessment of scarring quality using the Vancouver Scar Scale (VSS). |
| Incidents of Adverse Events | 1-10 weeks | To determine the difference in the frequency and nature of adverse events in participants receiving dHAICM versus SOC alone. |
Contacts
STUDY_DIRECTORStudy Director
Cellution Biologics
Outcome results
None listed