The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for donor site wounds in the community setting in the United Kingdom.
This prospective randomized controlled clinical study is being performed to evaluate the safety and performance of OASIS Extracellular Matrix when used as a treatment for donor site wounds as compared to standard wound care. This study will consent and treat up to 40 patients with 20 patients assigned to the OASIS treatment group and 20 patients assigned to the standard wound care treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Patients will receive OASIS Extracellular Matrix according to the Instruction for Use
Donor site will be treated with standard care.
Nursery Park Health Centre
Ashington, United Kingdom
Pinderfields Hospital
Wakefield, United Kingdom
Wound healing
To demonstrate the percentage of patients with wounds progressing to at least 50% healing
Time frame: 12 weeks
Wound closure- Percentage
Percentage of patients with complete wound closure
Time frame: up to 12 weeks
Wound closure- Mean number of weeks
mean number of weeks to complete wound closure
Time frame: up to 12 weeks
Wound closure- Mean Percentage
Mean percent wound closure
Time frame: up to 12 weeks
Patient reported Quality of Life measurement
The Wound Quality of Life (QoL) questionnaire is used for measurement of Health-Related Quality of Life in patients with chronic wounds. The total value of this measurement is derived from an average of 17 questions; each question has a value of a minimum of 1 and a maximum of 5. The lower the score, the better the outcome. Subscales are not combined to compute a total score.
Time frame: up to 12 weeks
Adverse Events
Summary of adverse events reported
Time frame: up to 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.