Study of Avelle™ Negative Pressure Wound Therapy (NPWT) S... | NCT05805046

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

NCT05805046

Sponsor

ConvaTec Inc.

Status

Withdrawn

Last Update Posted

Apr 30, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

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

Interventions

Negative Pressure Wound Therapy System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Convatec has identified an external source that has already collected relevant real-world data in a manner consistent with the proposed clinical study objectives.

Expanded Access Info

Start Date

Sep 30, 2023Actual

Primary Completion Date

Oct 30, 2023Actual

Completion Date

Oct 30, 2023Actual

First Submitted Date

Mar 28, 2023

First Submission Date that Met QC Criteria

Mar 28, 2023

First Posted Date

Apr 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2024

Last Update Posted Date

Apr 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.		Avelle™ Negative Pressure Wound Therapy System

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cristin Taylor	AWC Senior Director, Convatec	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Angel Medical Research Corp		Miami Lakes	Florida	33016	United States
Rush University Medical Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided