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Sponsors and Collaborators: |
Kuros Biosurgery AG Baxter BioScience |
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Information provided by: | Kuros Biosurgery AG |
ClinicalTrials.gov Identifier: | NCT00471939 |
This is a phase II, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB versus staples applied in the same patient to burn areas requiring autologous meshed skin grafting.
Condition | Intervention | Phase |
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Burns |
Drug: I-020502 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multi-Centre, Controlled Study of the Safety and Efficacy of Wound Healing Gel I-020502 (KUR-212) in Patients Undergoing Autologous Meshed Skin Grafting. |
Enrollment: | 10 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | January 2009 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte | |
Bochum, Germany, 44789 |
Principal Investigator: | Marcus Lehnhardt, Dr. | Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte |
Responsible Party: | Kuros Biosurgery AG ( Virginia Jamieson ) |
Study ID Numbers: | CS I-020502/01 |
Study First Received: | May 9, 2007 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00471939 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Burn, Meshed skin graft, PDGF deep partial thickness or full thickness burns |
Burns |