Full Thickness Thermal Burn
Conditions
Brief summary
Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for full-thickness (FT) burns. It works to close the wound, but can cause other problems: * Donor sites are painful, can become infected or scarred, or can even become FT wounds themselves * Treatment problems can require more grafting * Additional surgery increases risk of medical problems caused by the treatment Stratatech is trying to find a safe and effective treatment option for severe burns that uses less donor skin. All participants in this study received meshed autograft on one part of their burn (AG Tx). They received more widely meshed than AG Tx site autograft with a StrataGraft covering (SOMA Tx) on a different part of their burn.
Interventions
PROCEDUREAG Tx
Control treatment that is meshed autograft alone applied to a burn area.
BIOLOGICALSOMA Tx
Meshed autograft applied to the burn area and covered with StrataGraft.
Sponsors
Stratatech, a Mallinckrodt Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has 2% to 49% (inclusive) total body surface area (TBSA) thermal burn area, including areas of full thickness (FT) injury clinically indicated for surgical excision and autografting, appropriate for protocol-defined treatment areas * Meets protocol-specified criteria for qualification and contraception * Is willing and able to comply with all study procedures and requirements * Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Exclusion criteria
* Is a prisoner, pregnant, or had previous autografting to treatment sites * Is expected to survive less than 3 months * Is participating in another interventional trial, or did within 30 days before enrollment * Has anticipated treatment sites that are outside protocol-specified parameters * Has concurrent clinically significant inhalation injury, inadequate fluid resuscitation, or burns of chemical or electrical (non-thermal) etiology * Has other signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. The safety or well-being of the participant 2. The study objectives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2 | At Month 2 | Confirmed complete wound closure was defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart but no later than Week 20. Complete wound closure was considered to have occurred at the earlier of the 2 observations of complete skin re-epithelialization without drainage. The number of treatment sites with complete wound closure without additional autografting at Month 2 was reported. |
| Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12 | At Month 12 | Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 5 investigative sites in the United States from 10 October 2021 to 07 June 2024.
Pre-assignment details
The study was planned to be conducted in 2 cohorts. Only Cohort 1 data is reported, as the study was terminated before any participant was enrolled in Cohort 2. Total 13 participants were randomized in Cohort 1, each participant served as their own control. All participants had 2 treatment sites that were randomized to receive autograft treatment (AG Tx) at 1 treatment site, and StrataGraft overlay of meshed autograft (SOMA Tx) on the 2nd treatment site.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Group 1 Participants received AG Tx consisting of autograft alone (mesh ratio m, per clinical judgment) at 1 treatment site compared to SOMA Tx on other treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm\^2 in area on Day 1. | 7 |
| Cohort 1 Group 2 Participants received AG Tx consisting of autograft alone (mesh ratio m, per clinical judgment) at treatment site compared to SOMA Tx on other treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm\^2 in area on Day 1. | 6 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 2 | 2 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Cohort 1 Group 1 | Cohort 1 Group 2 | Total |
|---|---|---|---|
| Age, Continuous | 47.4 years STANDARD_DEVIATION 12.2 | 47.2 years STANDARD_DEVIATION 12.54 | 47.3 years STANDARD_DEVIATION 11.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 7 / 7 | 3 / 7 | 1 / 7 | 6 / 6 | 3 / 6 | 3 / 6 |
| serious Total, serious adverse events | 1 / 7 | 0 / 7 | 0 / 7 | 1 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12
Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure.
Time frame: At Month 12
Population: FAS included all participants who were randomized and treated with at least one area of SOMA Tx and one area of AG Tx. Here, the overall number analyzed of participants are the number of participants with data available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort1 Group1: AG Tx | Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12 | AG Tx Site | 6 Participants |
| Cohort1 Group1: AG Tx | Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12 | SOMA Tx Site | 6 Participants |
| Cohort1 Group1: SOMA Tx | Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12 | AG Tx Site | 3 Participants |
| Cohort1 Group1: SOMA Tx | Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12 | SOMA Tx Site | 3 Participants |
Primary
Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2
Confirmed complete wound closure was defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart but no later than Week 20. Complete wound closure was considered to have occurred at the earlier of the 2 observations of complete skin re-epithelialization without drainage. The number of treatment sites with complete wound closure without additional autografting at Month 2 was reported.
Time frame: At Month 2
Population: FAS included all participants who were randomized and treated with at least one area of SOMA Tx and one area of AG Tx.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort1 Group1: AG Tx | Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2 | 6 treatment sites |
| Cohort1 Group1: SOMA Tx | Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2 | 7 treatment sites |
| Cohort1 Group2: AG Tx | Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2 | 6 treatment sites |
| Cohort1 Group2: SOMA Tx | Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2 | 6 treatment sites |
Comparison: Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 1.p-value: 195% CI: [-11.64, 40.21]Fisher Exact
Comparison: Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 2.95% CI: [0, 0]