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Safety Study of VCT-01™ in Split-Thickness Skin Graft Donor Site Wounds

Wounds Clinical Trial

Official title:
A Single-Center, Prospective, Randomized Study of VCT-01™ in Split-Thickness Skin Graft Donor Site Wounds

Clinical Trial Summary

The purpose of this study is to evaluate the safety of VCT-01 in split-thickness skin graft (STSG) donor site wounds and assess selected parameters of healing at the VCT-01-treated donor site.

Clinical Trial Description

An initial cohort of 5 subjects will be allocated to Group A. When all subjects enrolled in Group A have completed 14 days of post-treatment follow-up, results of donor site evaluations, histological analyses and reported adverse events will be reviewed by the Investigator and study Sponsor. If the data is suggestive of clinical benefit following treatment and absent any serious and/or unexpected adverse events, which are, in the opinion of the investigator, related to the treatment, the remaining subjects will be enrolled and randomized to Groups B, C or D. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01292122
Study type Interventional
Source Organogenesis
Contact
Status Terminated
Phase N/A
Start date June 2011
Completion date September 2012
View Details
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