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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-30

Study Completion Date

2023-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

NCT05666570

Diabetic Foot Ulcer Venous Leg Ulcer

WITHDRAWN

ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds

NCT07342049

Venous Leg Ulcer (VLU)

NOT_YET_RECRUITING NA

Confirm the Safety and Performance of Avance Solo NPWT System

NCT04754048

Acute Wound Traumatic Wound Skin Graft +3 more

COMPLETED NA

A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a New Negative Pressure Wound Therapy (NPWT) System to be Used in the Treatment of Acute Non-infected Wounds and Post Surgical Infected Wounds

NCT01195896

Acute Non Infected Wounds Non Infected Post Surgical Wounds

COMPLETED NA

Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems

NCT04753294

Venous Leg Ulcer Pressure Ulcer Diabetic Foot Ulcer +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Avelle™ Negative Pressure Wound Therapy System

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No