Treatment of Wounds Using Oasis® ECM (17-001-CBI -version 1.3- 7/3/18)
Research type
Research Study
Full title
Treatment of Wounds Using Oasis® Extracellular Matrix (ECM)in the Community Setting
IRAS ID
246466
Contact name
Leanne Atkin
Contact email
Sponsor organisation
Cook Biotech, Inc.
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This is a single-arm, post-market, controlled, multi-center study with primary objective is to evaluate the performance, safety, and cost effectiveness of the Oasis ECM in the UK community setting. The percentage of patients with wounds progressing to at least 50% healing after up to 12 weeks of treatment will be used as the primary outcome measure. Secondary outcome measures will include the percentage of patients with complete wound healing after up to 12 weeks of treatment, mean number of weeks to complete wound healing, mean percentage wound healing (area change from baseline) at “best” visit, patient-reported quality of life (change in W-QoL score from baseline), summary of related Adverse Events reported during the study period, wound care-related resource use, (i.e. clinician visits, hospitalization, surgery, laboratory tests, number of Oasis applications, dressings and bandages) and final assessment of “quality care”, to include elements of patient safety, patient experience, and effectiveness of care. This study will be carried out in up to 2 clinical sites in the UK and designed to enrol up to 40 patients to ensure a robust enough sample size to support the drug tariff application in the UK and to ensure that different wound types are evaluated.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0238
Date of REC Opinion
3 Aug 2018
REC opinion
Further Information Favourable Opinion