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

Withdrawn

• Conditions: Trauma-related Wound; Surgical Wound Leak; Surgical Wound, Recent; Dehiscence Wound

• Registration Number: NCT05805046
• Lead Sponsor: ConvaTec Inc.

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 Timeline

• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-04-07
• Study Start: 2023-09-30
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Complete wound healing evidenced by substantially complete epithelialization (>95% by area estimate).	Up to 14 days	Primary performance outcome

Trial Locations

Locations (4)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

The Angel Medical Research Corp; 🇺🇸 Miami Lakes, Florida, United States

Northwell Health; 🇺🇸 Lake Success, New York, United States