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

Trauma-related Wound Clinical Trial

Official title:

Postmarket Clinical Follow-Up Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System in Patients With Acute Wounds

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05805046
• Other study ID #: WC22431
• Status: Withdrawn
• Start date: September 30, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: April 2024
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound
• Surgical Wound, Recent
• Trauma-related Wound
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	Northwell Health	Lake Success	New York
United States	The Angel Medical Research Corp	Miami Lakes	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete wound healing evidenced by substantially complete epithelialization (>95% by area estimate).	Primary performance outcome	Up to 14 days
Primary	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)	Primary safety outcome	Up to 14 days