Clinical trial NCT05805046: Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System
Official title: Postmarket Clinical Follow-Up Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System in Patients With Acute Wounds
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Surgical Wound, Recent
Surgical Wound Leak
Dehiscence Wound
Trauma-related Wound
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Complete wound healing evidenced by substantially complete epithelialization (>95% by area estimate).
timeFrame: Up to 14 days
measure: 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)
timeFrame: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: The Angel Medical Research Corp
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: AWC Senior Director, Convatec
name: Cristin Taylor
role: STUDY_DIRECTOR
References: