Treatment of Wounds Using Oasis® ECM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-26

Study Completion Date

2020-01-14

Brief Summary

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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 different types of chronic wounds in the community setting in the United Kingdom.

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Detailed Description

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Conditions

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Non-healing Wound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with chronic non-healing wounds

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

Oasis Extracellular Matrix

Intervention Type DEVICE

Patients will receive OASIS Extracellular Matrix according to the Instruction for Use

Interventions

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Oasis Extracellular Matrix

Patients will receive OASIS Extracellular Matrix according to the Instruction for Use

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No