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

ConvaTec Inc.

Overview

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?

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

Conditions

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

Interventions

Negative Pressure Wound Therapy SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

The Angel Medical Research Corp

Miami Lakes, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Northwell Health

Lake Success, New York, United States

The Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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

Primary performance outcome

Time frame: 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

Time frame: Up to 14 days

Data from ClinicalTrials.gov

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