Phase 3
N=71
StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
Burn, Thermal
Bottom Line
View on ClinicalTrials.gov: NCT03005106 ↗Enrolled (actual)
71
Serious AEs
14.1%
Results posted
Jul 2021
Primary outcome: Primary: Percent Area of Treatment Sites Requiring Autografting by Month 3 — 4.33; 102.10 percentage of treatment sites — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- StrataGraft Skin Tissue (Biological); Autograft (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stratatech, a Mallinckrodt Company
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Area of Treatment Sites Requiring Autografting by Month 3 |
4.33; 102.10 | <0.0001 sig |
| PRIMARY Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3) |
59 | — |
| SECONDARY Pain at the Designated Donor Sites by Day 14 |
0.15; 2.55 | <0.0001 sig |
| SECONDARY Total Scar Assessment (POSAS) Score by Observer at Month 3 |
6.3; 16.3 | <0.0001 sig |
Summary
About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat.
The burns will:
* be on 3-49% of the participant's total body surface area (TBSA)
* require surgery for skin replacement
* include intact dermal elements
The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged.
The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin.
All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one.
This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.
Eligibility Criteria
Inclusion Criteria
Subject-specific criteria:
- Men and women aged ≥ 18 years
- Written informed consent
- Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
- Clinical expectation that the study donor site will heal without grafting
- Complex skin defects of 3-49% TBSA
- Total burn may consist of more than one area
Treatment site-specific criteria:
- Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
- Total of both study treatment areas can be up to 2000 cm2
- First excision and grafting of study treatment sites
- Thermal burn(s) on the torso, arms, or legs
Exclusion Criteria
Subject-specific criteria:
- Pregnant women
- Prisoners
- Subjects receiving systemic immunosuppressive therapy
- Subjects with a known history of malignancy
- Preadmission insulin-dependent diabetic subjects
- Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
- Expected survival of less than three months
- Participation in the treatment group of an interventional study within 90 days prior to enrollment
Treatment site-specific criteria:
- Full-thickness burns
- Chronic wounds
- The face, head, neck, hands, feet, buttocks, and area over joints
- Treatment sites immediately adjacent to unexcised eschar
- Clinical or laboratory determination of infection at the anticipated treatment sites
Data sourced from ClinicalTrials.gov (NCT03005106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.