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

NCT05805046 | Withdrawn FDA Device

• 1 other identifier: WC22431
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 4

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?

Conditions

Surgical Wound, Recent; Surgical Wound Leak; Dehiscence Wound; Trauma-related Wound

Outcome Measures

Primary Outcomes (2)

• Complete wound healing evidenced by substantially complete epithelialization (>95% by area estimate).

  Primary performance outcome

  Up to 14 days

• 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

Interventions

Negative Pressure Wound Therapy System DEVICE

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.

Also known as: Avelle™ Negative Pressure Wound Therapy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Negative pressure wound therapy is used to assist in the management of a closed surgical wound or other acute wound expected to heal by way of primary intention.

You may qualify if:

• 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.

You may not qualify if:

• 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 is contraindicated for the Avelle™ NPWT System

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (4)

The Angel Medical Research Corp

Miami Lakes, Florida, 33016, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Cristin Taylor

  AWC Senior Director, Convatec

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 7, 2023
• Study Start: September 30, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)