Trials / Withdrawn
WithdrawnNCT05805046
Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System
Postmarket Clinical Follow-Up Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System in Patients With Acute Wounds
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- ConvaTec Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Negative Pressure Wound Therapy System | The study device combines a sterile dressing comprising gelling fibre technology to absorb wound exudate with negative pressure applied to the wound via a vacuum pump. |
Timeline
- Start date
- 2023-09-30
- Primary completion
- 2023-10-30
- Completion
- 2023-10-30
- First posted
- 2023-04-07
- Last updated
- 2024-04-30
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05805046. Inclusion in this directory is not an endorsement.