Treatment of Wounds Using Oasis® ECM

Cook Group

Status: Completed

Conditions: Non-healing Wound

Treatments: Device: Oasis Extracellular Matrix; Other: Standard Care (in control arm)

Study type: Interventional

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 donor site wounds in the community setting in the United Kingdom.

Full description

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.

Enrollment: 41 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

20 patients assigned to the OASIS treatment group

Experimental group

Description:

After skin graft is taken, OASIS will be applied to the donor site.

Treatment:

Device: Oasis Extracellular Matrix

20 patients assigned to the standard wound care

Active Comparator group

Description:

After skin graft is taken, donor site will be treated with standard wound care.

Treatment:

Other: Standard Care (in control arm)