StrataGraft Skin Tissue

BIOLOGICAL5 trials

Sponsors

Stratatech, a Mallinckrodt Company

Conditions

Burn, ThermalBurnsDeep Partial-thickness BurnDegloving InjurySkin WoundThird Degree BurnTrauma-related WoundWound Infection

Phase 1

StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects

CompletedNCT00618839

Stratatech, a Mallinckrodt CompanyBurns, Degloving Injury, Third Degree Burn +1

Start: 2006-07-31End: 2008-04-30Updated: 2019-10-16

StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns

CompletedNCT01437852

Stratatech, a Mallinckrodt CompanyBurns, Skin Wound, Trauma-related Wound

Start: 2011-09-30End: 2014-10-31Updated: 2019-10-16

Phase 2

StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

TerminatedNCT03005054

Stratatech, a Mallinckrodt CompanyBurns, Skin Wound, Trauma-related Wound

Start: 2017-04-24End: 2019-03-26Updated: 2021-08-03

Phase 3

StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

CompletedNCT03005106

Stratatech, a Mallinckrodt CompanyBurn, Thermal

Start: 2017-05-30End: 2020-03-27Updated: 2021-07-14

StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )

CompletedNCT04123548

Stratatech, a Mallinckrodt CompanyDeep Partial-thickness Burn

Start: 2020-02-18End: 2022-01-26Updated: 2023-11-09

Related Papers

A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft® treatment in adults with deep partial-thickness thermal burns.

2024-06-061 citations

52 Open-Label, Expanded-Access Study of a Bioengineered Allogeneic Cellularized Construct in Adults With Deep Partial-Thickness Burns

Journal of Burn Care & Research2023-05-011 citations

Pooled safety analysis of STRATA2011 and STRATA2016 clinical trials evaluating the use of StrataGraft® in patients with deep partial-thickness thermal burns.

2022-07-285 citations

89 Pooled Safety Analysis Evaluating Bioengineered Allogeneic Cellularized Construct in Patients with Deep Partial-thickness Thermal Burns

Journal of Burn Care & Research2022-03-23

A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft® construct in patients with deep partial-thickness thermal burns

Burns2021-04-2335 citations

31 A phase 3 open-label, controlled, randomized trial evaluating the efficacy and safety of a bioengineered allogeneic cellularized construct in patients with deep partial-thickness thermal burns

Journal of Burn Care & Research2021-04-01

T5 Preliminary Analysis of a Phase 3 Open-label, Controlled, Randomized Trial Evaluating the Efficacy and Safety of a Bioengineered Regenerative Skin Construct in Patients with Deep Partial-thickness Thermal Burns

Journal of Burn Care & Research2020-03-011 citations

StrataGraft skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds: results from a prospective, randomized, controlled dose escalation trial.

2011-04-0162 citations