Evaluating Clinical Acceptance of a NPWT Wound Care System
| Status: | Recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | October 16, 2018 |
| End Date: | September 20, 2019 |
| Contact: | Joan Wilson, MSN, MHA, RN |
| Email: | joan.wilson@jmsresearchfoundation.org |
| Phone: | 706-364-2966 |
Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types
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.
the goal of therapy when treating patients with a variety of wound types during the
evaluation period.
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
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
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patient not willing to comply with f/u clinic visits.
- 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.
- Patients with concurrent conditions or co-morbidities that in the opinion of the
investigator may compromise patient safety or study objectives.
We found this trial at
1
site
Augusta, Georgia 30909
Principal Investigator: Robert F Mullins, MD
Phone: 706-364-2966
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