Feasibility Study to compare OASIS with Standard Wound Care
Research type
Research Study
Full title
Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds
IRAS ID
270990
Contact name
Zeeshan Sheikh
Contact email
Sponsor organisation
Cook Biotech Incorporated
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This is a prospective, randomised-controlled, 2-arm, post-market, single-center feasibility study. The primary objective is to evaluate the safety and performance of the Oasis ECM when used as a treatment for donor site wounds as compared to standard wound care. The percentage of patients with donor site wounds progressing to fully healed at day 14 will be used as the primary outcome measure. Secondary outcome measures will include pain as perceived by the patient, cosmetic outcome and frequency of complications such as infection, seroma and haematoma, reported during the study period. This study will be carried out at one clinical site in the UK and is designed to enrol up to 40 patients (20 in each group) to ensure a robust sample size.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
19/NW/0664
Date of REC Opinion
4 Feb 2020
REC opinion
Further Information Favourable Opinion