Evaluating Clinical Acceptance of a NPWT Wound Care System
- Conditions
- Diabetic Foot UlcerPressure InjuryPressure Ulcer
- Interventions
- Device: Invia Motion Endure
- Registration Number
- NCT03670225
- Lead Sponsor
- Medela AG
- Brief Summary
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.
- Detailed Description
The primary objective of this study is to determine acceptable progress towards the goal of therapy for a diabetic foot ulcers (DFU) and pressure Injuries/ulcers (PI/PU) wounds 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
* 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\*\*
B. Secondary Objectives
* To evaluate the ease of use from clinicians.
* To evaluate overall satisfaction from clinicians. C. Tertiary Objectives
* Adequate management of the exudate
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- Adult subjects ≥18 years of age.
- Signed, informed consent by patient or LAR within 72 hours of admission to burn center.
- Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries/pressure ulcer.
- Patient is comfortable (e.g. not in pain)
- Patient is willing and able to adhere to treatment protocol.
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Patient not willing to comply with f/u clinic visits.
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Subjects with
- Necrotic tissue with eschar present
- Untreated osteomyelitis
- Non-enteric and unexplored fistulas
- Malignancy in wound
- Exposed vasculature
- Exposed nerves
- Exposed anastomotic site of blood vessels or bypasses
- Exposed organs
-
Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
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Patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Invia Motion Endure Invia Motion Endure -
- Primary Outcome Measures
Name Time Method Determine if Invia Motion Endure supports acceptable progress towards the goal of therapy for DFU and PI/PU wounds 4 weeks Goal of the therapy will be defined by the physician according to initial assessment:
* 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
* 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 enrolment, when the goal of therapy is documented\*\*
- Secondary Outcome Measures
Name Time Method Evaluation of ease of use and satisfaction 4 weeks A weekly survey will be obtained from the wound clinic staff members to determine ease of use and satisfaction
Trial Locations
- Locations (1)
Joseph M. Still Research Foundation
🇺🇸Augusta, Georgia, United States