Date: 2016-05-02
Type of information: Results
phase:
Announcement: results
Company: Osiris Therapeutics (USA - MD)
Product: Grafix®
Action
mechanism: Grafix® is a cryopreserved placental membrane for acute and chronic wounds. It is a flexible, conforming membrane that is applied directly at the site of the wound. Grafix is produced by Osiris' BioSmart™ Intelligent Tissue Processing which maintains the integrity of the extracellular matrix, growth factors, and endogenous fibroblasts, epithelial cells and mesenchymal stem cells of the native tissue.
Disease: acute and chronic wounds
Therapeutic area:
Country:
Trial
details: The patient population consisted of all male and female patients (n=79) over the age of 18 years, who received at least one application of either Grafix or EpiFix between February 2014 and March 2016 at Bozeman Health Deaconess Hospital , Wound and Hyperbaric Center. Consistent with the terms and conditions dictated by the Health Insurance Portability Act of 1996 (HIPPA), de-identified information was obtained from the electronic health record database for the purposes of a retrospective comparative effectiveness analysis between patients receiving either Grafix or EpiFix. The primary analysis was pre-specified in a retrospective clinical efficacy study protocol as the proportion of index wounds achieving complete closure. Osiris Therapeutics partnered with a statistical data management organization that performed the blinded independent analysis of the data.
Latest
news: * On May 2, 2016, Osiris Therapeutics announced the results of A Retrospective, Single-Center, Non-Randomized, Cross-Sectional Comparative Effectiveness Study Evaluating Surface Area Reduction, Volume Reduction and Closure Rates in Acute and Chronic Wounds Managed with Grafix® versus EpiFix®.
The primary objective of this investigator initiated study was to compare the efficacy of Grafix® to EpiFix® in a real world clinical setting. Per a protocol, all patients over the age of 18 that received at least one application of either Grafix or EpiFix for the management of any head-to-toe acute or chronic wound between February 2014 and March 2016 were included in the study. The primary analysis was the proportion of index wounds that achieved complete closure during the retrospective treatment period. Blinded statistical analyses for both Grafix and EpiFix treatment groups were performed by an independent third party clinical research organization.
A total of 79 patients with 101 wounds were identified for study analysis: 39 patients with 55 wounds received EpiFix and 40 patients with 46 wounds received Grafix. There were no patients or wound types excluded. Researchers used a pre-defined protocol to collect de-identified electronic health records from the wound care management software. The mean wound surface area at presentation was 7.7 cm2 in the Grafix group and 7.0 cm2 in the EpiFix group. The mean wound volume at presentation was 8.3 cm3 in the Grafix group and 2.7 cm3 in the EpiFix group. There were no statistical differences in the basic demographics between the two groups.
The proportion of complete wound closure was 63.0% (29/46) for the Grafix group and 18.2% (10/55) for the EpiFix group (p < 0.0001). 90% of wounds, 26/29 in the Grafix group and 9/10 in the EpiFix group, achieved closure by week 12.
The mean baseline surface area for closed wounds was 9.4 cm2 in the Grafix group and 2.1 cm2 in the EpiFix group.
The mean baseline volume for closed wounds was 10.3 cm3 in the Grafix group and 0.55 cm3 in the EpiFix group.
For wounds that did not reach complete closure during the study period, a mean 43% surface area reduction and a mean 40% reduction in volume was recorded for Grafix-treated wounds versus a mean 73% increase in surface area and a 136% increase in volume for EpiFix-treated wounds.
When compared to EpiFix, researchers determined that Grafix closed more wounds with surface areas that were over 4x greater in size and 19x greater in volume. The Grafix-treated wounds that did not achieve closure during the study period demonstrated clinically effective improvement with an average surface area and volume reduction of greater than 40%. By comparison, the unclosed EpiFix-treated wounds demonstrated a deterioration in clinical condition as evidenced by an average increase in surface area and volume of greater than 104%.
The results demonstrated by Grafix in this real world study are consistent with the previously published RCT data in which Lavery reported a 62% complete wound closure rate by 12 weeks in a large, blinded, multicenter DFU trial ( Lavery et al., 2014).
