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

Study Overview
=================
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

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

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

Intervention / Treatment
-----------------
* Device: Negative Pressure Wound Therapy System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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, in the opinion of the Investigator, is not clinically suitable for inclusion Subject is contraindicated for the Avelle™ NPWT System

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

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 |