WP07: Data Analysis

Objectives

The main objective of Workpackage 07 is the conduction of the data analysis of all clinical trial data. Input will come from the clinical trial partners and will be conducted with assistance from the Clinical Trial Center in Zurich (Partner 01c UZH-CTC).

Data analysis will include review and analysis of data from Phase 1 (safety) and Phase 2 clinical trials of the whole project (effectivity of the three test materials versus their controls).

Workpackage Description

In the first part of the project, a phase I trial will be conducted on the three products denovoDerm, denovoSkin and NovoMaix aiming at  safe and uncomplicated application of test products in patient wounds. Complications will be evaluated against normal complication rates for the specific type of treatment, bacterial contamination, take of test material and skin graft, progress of wound healing, necessity to re-operate will be monitored. In tissue biopsies, foreign body reaction will be monitored.
 
Secondly, phase II trials will be started to demonstrate adequate take rate and wound closure of skin graft on test products denovoDerm and NovoMaix in a 1 step application procedure. Take rate and wound closure will be determined by planimetry at 5-10 days after application, bacterial contamination and necessity to re-operate will be monitored. Similarly, for denovoSkin take and wound closure will be analysed in comparison to gold standard.

As long term outcome parameters primary end point parameters will be analyzed at the end of the follow up period of the phase II trials  versus the respective controls. Also, secondary end point parameters as defined per protocol will be analyzed, objective measurement tools will be used to determine quality of healing.