Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System

Launched by CONVATEC INC. · Mar 28, 2023

Keywords

ClinConnect Summary

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:

* be asked questions about their m...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is ≥ 18 years of age.
• • 2. Subject is willing and able to take part in the study and provide written informed consent.
• • 3. Subject has one target wound which is ≤ 14 days old
• • 4. Subject has target wound that is intended to heal by primary intention
• • 5. Subject has a target wound which is ≤ 25% of the dressing area as per the Instructions For Use
• • 6. Target wound has low to moderate exudate
• • 7. Wound is suitable for treatment with Avelle™ NPWT
• • 8. Subject is deemed capable and willing to comply with the protocol and product instructions.
• Exclusion Criteria:
• • 1. 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
• • 2. Subject has been treated with another NPWT system during the past 14 days
• • 3. Subject, in the opinion of the Investigator, is not clinically suitable for inclusion
• • 4. Subject is contraindicated for the Avelle™ NPWT System