An observational study in Surgical Wound, Recent, Surgical Wound Leak and Dehiscence Wound, sponsored by ConvaTec Inc.. Withdrawn at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by ConvaTec Inc. · Observational
The main questions the study aims to answer are:
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:
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
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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.
Exclusion Criteria:
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.
Also known as: Avelle™ Negative Pressure Wound Therapy System
Complete wound healing evidenced by substantially complete epithelialization (>95% by area estimate).
Primary performance outcome
Time frame: 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
Time frame: Up to 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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ConvaTec Inc.