Invia Motion Endure NPWT system
Devicelightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options
NCT Number: NCT04593693
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Joseph M. Still Burn Center and Wound Clinic at Doctors Hospital, Augusta, Georgia, United States
The primary objective is to evaluate whether clinical opinion of product performance results in expected wound response and outcomes when using the Medela Invia Motion Endure NPWT system during 4-week study duration.
Endpoints (dependent on goal of therapy):
**Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented**
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and length, width and depth of the wound measured during treatment until goal of the therapy is reached
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the tunneling of the wound measured during treatment until goal of the therapy is reached
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the undermining of the wound measured during treatment until goal of the therapy is reached
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the amount of slough measured during treatment until goal of the therapy is reached
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the amount of granulation tissue measured during treatment until goal of the therapy is reached
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the presence of edema determined during treatment until goal of the therapy is reached
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the wound bed visually determined during treatment until goal of the therapy is reached
Time frame: Up to 4 week study duration
A weekly staff satisfaction survey will be obtained from the wound clinic staff members to determine ease of use on a scale from higher to worse score with four values (more satisfied, satisfied, neutral, less satisfied)
Time frame: Up to 4 week study duration
A weekly staff satisfaction survey will be obtained from the wound clinic staff members to determine overall satisfaction with the device on a scale from higher to worse score with four values (more satisfied, satisfied, neutral, less satisfied)
Time frame: Up to 4 week study duration
A weekly staff satisfaction survey on the ability to maintain dressing seal will be obtained from the wound clinic staff members to determine performance satisfaction of dressing components on periwound on a scale from higher to worse score with four values (more satisfied, satisfied, neutral, less satisfied)
Medela AG
Industry
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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