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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Wound, Recent; Trauma-related Wound; Dehiscence Wound; Surgical Wound Leak
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Estimated): 59

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami Lakes, Florida, United States, 33016
      • The Angel Medical Research Corp
      • Contact: Angel Achong; Phone Number: 786-542-5820; Email: achong@theangelresearch.com
      • Principal Investigator: John Dylewski
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
      • Principal Investigator: Thea Price
      • Contact: Matthew Johnson; Phone Number: 312-942-1735; Email: matthew_johnson@rush.edu
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health
      • Principal Investigator: Alisha Oropallo
      • Contact: Sally Kaplan; Phone Number: 516-562-4578; Email: skaplan2@northwell.edu
  • Ohio
    • Columbus, Ohio, United States, 43210
      • the Ohio State University
      • Contact: Adara McCarty; Phone Number: 614-685-5568; Email: Adara.McCarty@osumc.edu
      • Principal Investigator: Jon Wisler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Study Chair: Kerem Ozer, MD, Convatec Advanced Wound Care Director

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2023
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: WC22431

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No