Artificial skin enters donor site trial:
This article was originally published in Clinica
Executive Summary
Tissue engineering company Ortec International is to begin a pivotal clinical trial of its Composite Cultured Skin (CCS) product on burn victims. The US FDA granted New York-based Ortec permission to begin trials of CCS to close donor site wounds. The new trial will involve 75 patients at 12 burn centres in the US and its primary endpoint will compare time to wound closure versus standard wound dressings, with a six-month follow up. A pilot study of eight patients showed that CCS closed wounds an average 9.5 days earlier than a control dressing (see Clinica No 853, p 25).