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Safety and Efficacy of I-020502 in Meshed Skin Autografting

NCT00471939 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2009-03-03

No results posted yet for this study

Summary

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.

Conditions

  • Burns

Interventions

DRUG

I-020502

1 mcg/mL TG-PDGF.AB

Sponsors & Collaborators

  • Baxter BioScience

    collaborator INDUSTRY

  • Kuros Biosurgery AG

    lead INDUSTRY

Principal Investigators

  • Marcus Lehnhardt, Dr. · Universitätsklinik für Plastische Chirurgie und Schwerbrandverletzte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2007-12-31
Completion
2009-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00471939 on ClinicalTrials.gov