drugset / Trial / NCT00618839
StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects
Phase 1/2
Completed
15 enrolled
Stratatech, a Mallinckrodt Company
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · collab
NaSingle-groupOpen-labelTreatment
Summary
This pilot Phase I/II clinical study will be conducted at up to three clinical sites. This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects. The patients are intended to undergo sequential surgical procedures involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at various separate or contiguous wound sites. Patients will be randomized within each wound site to one of two test products: cadaver skin or StrataGraft™ skin tissue.
Timeline
- Start
- 2006-07
- Primary completion
- 2008-04
- Completion
- 2008-04
Publications
- Results Schurr MJ, Foster KN, Centanni JM, Comer AR, Wicks A, Gibson AL, Thomas-Virnig CL, Schlosser SJ, Faucher LD, Lokuta MA, Allen-Hoffmann BL. Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009 Mar;66(3):866-73; discussion 873-4. doi: 10.1097/TA.0b013e31819849d6.
- Results Centanni JM, Straseski JA, Wicks A, Hank JA, Rasmussen CA, Lokuta MA, Schurr MJ, Foster KN, Faucher LD, Caruso DM, Comer AR, Allen-Hoffmann BL. 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. Ann Surg. 2011 Apr;253(4):672-83. doi: 10.1097/SLA.0b013e318210f3bd.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | StrataGraft | Other / unclassified | 0.5 % | — |
| Subject | StrataGraft | Other / unclassified | 1 % | — |
| Subject | StrataGraft | Other / unclassified | 1.5 % | — |