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StrataGraft
StrataGraft is a bioengineered human skin substitute used to treat severe burns.
StrataGraft is a bioengineered human skin substitute used to treat severe burns. Used for Treatment of severe burns.
At a glance
| Generic name | StrataGraft |
|---|---|
| Sponsor | Stratatech, a Mallinckrodt Company |
| Drug class | Skin substitute |
| Modality | Biologic |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
StrataGraft is a bilayered, living skin substitute composed of a dermal layer and an epidermal layer. It is designed to promote wound healing and tissue regeneration.
Approved indications
- Treatment of severe burns
Common side effects
- Wound infection
- Delayed healing
Key clinical trials
- StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (PHASE1, PHASE2)
- StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects (PHASE3)
- StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT ) (PHASE3)
- Scarring in Stratagraft-treated vs. Autograft-treated Burn Wounds: a Clinical and Histological Investigation
- StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects (PHASE2)
- StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements (PHASE3)
- StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects (PHASE1, PHASE2)
- StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- StrataGraft CI brief — competitive landscape report
- StrataGraft updates RSS · CI watch RSS
- Stratatech, a Mallinckrodt Company portfolio CI