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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 patients assigned to the OASIS treatment group | Experimental | After skin graft is taken, OASIS will be applied to the donor site. |
|
| 20 patients assigned to the standard wound care | Active Comparator | After skin graft is taken, donor site will be treated with standard wound care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oasis Extracellular Matrix | Device | Patients will receive OASIS Extracellular Matrix according to the Instruction for Use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | To demonstrate the percentage of patients with wounds progressing to at least 50% healing | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound closure- Percentage | Percentage of patients with complete wound closure | up to 12 weeks |
| Wound closure- Mean number of weeks | mean number of weeks to complete wound closure |
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Inclusion Criteria:
1. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leanne Atkin, PhD | Mid Yorkshire Teaching NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nursery Park Health Centre | Ashington | United Kingdom | ||||
| Pinderfields Hospital |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014648 | Varicose Veins |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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A patient is suitable for inclusion in the study if the patient meets the following criteria, based on known information at the time of enrolment:
1. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting
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| Standard Care (in control arm) | Other | Donor site will be treated with standard care. |
|
| up to 12 weeks |
| Wound closure- Mean Percentage | Mean percent wound closure | 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. | up to 12 weeks |
| Adverse Events | Summary of adverse events reported | up to 12 weeks |
| Wakefield |
| United Kingdom |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |