Oasis Donor Site Wounds Post-Market Study
The purpose of this study is to demonstrate the safety and performance of Oasis extracellular matrix (ECM) when used as a treatment for donor site wounds in the United Kingdom. Oasis ECM is commercially available for the treatment of partial and full-thickness skin wounds, including chronic wounds, wounds from trauma,
| Condition(s) | Surgical Wound, Wound, Wounds and Injuries, Wound Heal |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The purpose of this study is to demonstrate the safety and performance of Oasis extracellular matrix (ECM) when used as a treatment for donor site wounds in the United Kingdom. Oasis ECM is commercially available for the treatment of partial and full-thickness skin wounds, including chronic wounds, wounds from trauma, and wounds that occur during surgery, such as donor site wounds. The ability of the Oasis ECM to promote the healing of donor site wounds will be evaluated in this study. About 40 patients (20 in each arm) over 16 years old will be involved in this study at one center in the United Kingdom. |
| Who can participate | Inclusion Criteria: 1. Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a covering material. 2. Has at least 24 hours to consent to study participation. Exclusion Criteria: 1. Age \< 16 years 2. Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as: 1. Chronic inflammatory skin condition 2. Chronic liver failure 3. Chronic renal failure 4. Blood-borne viruses (Hep B, Hep C, HIV) 5. Peripheral vascular disease 6. Clinically significant anaemia 7. Uncontrolled diabetes 3. Need for use of the same harvest site (re-cropping) 4. History of radiation therapy to proposed donor site 5. Chronic use of medications known to impair wound healing 6. Chronic use of opioids or neuropathic |
| Ages | 16 Years |
| Sex | All |
| Lead sponsor | Cook Biotech Incorporated |
| Locations | Manchester, England, United Kingdom |
| Start date | 2020-11-01 |
| NCT ID | NCT04079348 |
| Official listing | https://clinicaltrials.gov/study/NCT04079348 |