Treatment of Wounds Using Oasis® ECM

Cook Group

Status: Completed

Conditions: Non-healing Wound

Treatments: Device: Oasis Extracellular Matrix

Study type: Observational

Funder types: Industry

Identifiers

NCT03632031

17-001

Details and patient eligibility

About

The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for different types of chronic wounds in the community setting in the United Kingdom.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. Age < 18 years
2. Unable or unwilling to provide informed consent
3. Unable or unwilling to comply with the study follow-up schedule, and procedures
4. Simultaneously participating in another investigational drug or device study
5. Target wound area is < 2 cm2 or > 140 cm2 after baseline debridement
6. Target wound has reduced in area by > 40% with 4 weeks of documented standard of care therapy
7. Known allergy to pig or porcine products
8. Systemic infection
9. Infection of the target wound as determined by the collection of pus
10. Osteomyelitis
11. ABI/TBI < 0.6 obtained within 3 months prior to the screening visit
12. Other exclusions may apply

Trial design

40 participants in 1 patient group

Patients with chronic non-healing wounds

Description:

Patients with chronic non-healing wounds with planned use of OASIS Extracellular Wound Matrix

Treatment:

Device: Oasis Extracellular Matrix