Surgical Wound, RecentNCT05805046
Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System
An observational study of Surgical Wound, Recent and Surgical Wound Leak, run by ConvaTec Inc. at 4 sites in United States.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound, Recent, Surgical Wound Leak, Dehiscence Wound
- What is being tested?
- Negative Pressure Wound Therapy System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Sep 2023to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rush University Medical Center
Chicago, Illinois, 60612
The Ohio State University
Columbus, Ohio, 43210
Northwell Health
Lake Success, New York, 11042
The Angel Medical Research Corp
Miami Lakes, Florida, 33016
About this study
Official title: Postmarket Clinical Follow-Up Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System in Patients With Acute Wounds
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?
Read the 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
- Being tested
- Negative Pressure Wound Therapy System
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound Therapy SystemDevice
Also called Avelle™ 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 being measured
The primary outcome is the main question the study is designed to answer.
Complete wound healing evidenced by substantially complete epithelialization (>95% by area estimate).
Primary performance outcome
Measured: 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
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start30 Sep 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound, RecentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cristin Taylor, Study director, AWC Senior Director, Convatec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805046
- Sponsor's protocol ID
- WC22431
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarket Clinical Follow-Up Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System in Patients With Acute Wounds
- ClinicalTrials.gov ID
- NCT05805046
- Acronym / sponsor ID
- WC22431
- Study type
- Observational
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound Therapy SystemAlso: Avelle™ Negative Pressure Wound Therapy SystemThe 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. | Device | – |
Primary outcome
Complete wound healing evidenced by substantially complete epithelialization (>95% by area estimate).
Time frame: Up to 14 days
Primary performance outcome
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)
Time frame: Up to 14 days
Primary safety outcome
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristin Taylor study director
AWC Senior Director, Convatec
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound, Recent and Surgical Wound Leak, run by ConvaTec Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound healing evidenced by substantially complete epithelialization (>95% by area estimate). (time frame: Up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.