Postmarket Clinical Follow-Up Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System in Patients With Acute Wounds
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- ConvaTec Inc.
- Locations
- 4
- Primary Endpoint
- 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)
Study Overview
Brief Summary
The main questions the study aims to answer are:
- How much do wounds improve when using the Avelle™ Negative Pressure Wound Therapy System for a maximum of 14 days?
- How safe is the Avelle™ Negative Pressure Wound Therapy System?
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:
- be asked questions about their medical history and medications
- asked to allow the wound and surrounding skin to be examined
- be asked to use the Avelle™ Negative Pressure Wound Therapy System for a maximum of 14 days
- be asked to review any issues or concerns with the Avelle™ Negative Pressure Wound Therapy System
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is ≥ 18 years of age.
- •Subject is willing and able to take part in the study and provide written informed consent.
- •Subject has one target wound which is ≤ 14 days old
- •Subject has target wound that is intended to heal by primary intention
- •Subject has a target wound which is ≤ 25% of the dressing area as per the Instructions For Use
- •Target wound has low to moderate exudate
- •Wound is suitable for treatment with Avelle™ NPWT
- •Subject is deemed capable and willing to comply with the protocol and product instructions.
Exclusion Criteria
- •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
- •Subject has been treated with another NPWT system during the past 14 days
- •Subject, in the opinion of the Investigator, is not clinically suitable for inclusion
- •Subject is contraindicated for the Avelle™ NPWT System
Outcomes
Primary Outcomes
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)
Time Frame: Up to 14 days
Primary safety outcome
Complete wound healing evidenced by substantially complete epithelialization (>95% by area estimate).
Time Frame: Up to 14 days
Primary performance outcome
Secondary Outcomes
No secondary outcomes reported