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| Name | Class |
|---|---|
| Baxter BioScience | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-020502 | Drug | 1 mcg/mL TG-PDGF.AB |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events up to 28 days post surgery | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AE/SAE, Changes in vital signs, Hematology/clinical chemistry, PDGF.AB/TG-PDGF.AB and antibodies, hypergranulation, Percentage and proportion of re-epithelialization/engraftment, Scar assessment, Time and resources for test site treatments | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Lehnhardt, Dr. | Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte | Bochum | 44789 | Germany |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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