NCT01292122

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Organogenesis · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Wounds

Interventions

Type	Name	Description
DEVICE	VCT-01	Application of bi-layered living cell-based product (VCT-01) to STSG donor site wound at Day 0

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-02-09
• Last updated: 2012-12-20

Locations

1 site across 1 country: Canada