A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Wound
- Dehiscence
- Diabetic Foot Ulcer
- Edema
- Pressure Injury
- Pressure Ulcer
- Surgical Wound
- Traumatic Wound
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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. * Goal of therapy will be defined by the physician according to initial assessment:...
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. * Goal of therapy will be defined by the physician according to initial assessment: Endpoints (dependent on goal of therapy): Decrease in wound volume Decrease in size of the tunneling area Decrease in size of undermining Decrease in amount of slough Increase in granulation tissue Decrease in edema/periwound swelling The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft. **Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented**
Tracking Information
- NCT #
- NCT04593693
- Collaborators
- Joseph M. Still Research Foundation, Inc.
- Investigators
- Principal Investigator: Claus Brandigi, MD Joseph M. Still Research Foundation, Inc.
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