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

Sponsored by ConvaTec Inc.

About this trial

Last updated a year ago

Study ID

WC22431

Status

Withdrawn

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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?

What are the participation requirements?

Yes

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.

No

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

Locations

Location

Status