Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System
Study Details
Study Description
Brief Summary
The main questions the study aims to answer are:
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How much do wounds improve when using the Avelle™ Negative Pressure Wound Therapy System for a maximum of 14 days?
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How safe is the Avelle™ Negative Pressure Wound Therapy System?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The goal of this observational study is to gather information about the the Avelle™ Negative Pressure Wound Therapy System in people that have a wound that leaks fluid and is 14 days old or less. The Avelle™ Negative Pressure Wound Therapy (NPWT) System combines a sterile dressing comprising gelling fibre technology to absorb wound exudate with negative pressure applied to the wound via a vacuum pump. The Avelle™ NPWT System consists of a disposable single patient use battery powered pump, absorbent wound dressing, and fixation strips.
Participants will:
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be asked questions about their medical history and medications
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asked to allow the wound and surrounding skin to be examined
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be asked to use the Avelle™ Negative Pressure Wound Therapy System for a maximum of 14 days
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be asked to review any issues or concerns with the Avelle™ Negative Pressure Wound Therapy System
Study Design
Outcome Measures
Primary Outcome Measures
- Complete wound healing evidenced by substantially complete epithelialization (>95% by area estimate). [Up to 14 days]
Primary performance outcome
- Frequency of device-related serious adverse events (SAEs) (all adverse events attributed to the wound and or device will be collected and assessed as non-device related or device related, and serious or non-serious, by the Investigator) [Up to 14 days]
Primary safety outcome
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is ≥ 18 years of age.
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Subject is willing and able to take part in the study and provide written informed consent.
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Subject has one target wound which is ≤ 14 days old
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Subject has target wound that is intended to heal by primary intention
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Subject has a target wound which is ≤ 25% of the dressing area as per the Instructions For Use
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Target wound has low to moderate exudate
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Wound is suitable for treatment with Avelle™ NPWT
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Subject is deemed capable and willing to comply with the protocol and product instructions.
Exclusion Criteria:
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Subject has an existing health condition that would compromise their participation and follow-up in this study such as the ability to understand and follow instructions
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Subject has been treated with another NPWT system during the past 14 days
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Subject, in the opinion of the Investigator, is not clinically suitable for inclusion
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Subject is contraindicated for the Avelle™ NPWT System
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Angel Medical Research Corp | Miami Lakes | Florida | United States | 33016 |
| 2 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 3 | Northwell Health | Lake Success | New York | United States | 11042 |
| 4 | The Ohio State University | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- ConvaTec Inc.
Investigators
- Study Chair: Kerem Ozer, MD, Convatec Advanced Wound Care Director
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WC22431