Acute and Chronic Wounds, Diabetic Foot Ulcers, Pressure Ulcers, Trauma Wounds, Venous Stasis Ulcers
Conditions
Keywords
negative pressure wound therapy, NPWT, Spiracur, SNaP Wound Care System
Brief summary
The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in order to optimize safety, efficacy, and system performance.
Interventions
DEVICESNaP Wound Care System
The intervention is negative pressure wound therapy (NPWT) with the Spiracur SNaP Wound Care system for the treatment of a variety of acute and chronic wounds including pressure ulcers, trauma wounds, diabetic foot ulcers, venous stasis ulcers, and skin grafts. The Spiracur SNaP Wound Care system weighs less than 4 ounces, does not utilize an electric pump (device has no electrically powered parts), is fully disposable after use, and is designed for particularly small chronic wounds that require advanced wound care management. It delivers NPWT at a constant pressure level over several days without any required adjustments by the patient or clinician.
Sponsors
3M
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Wound \< 10 cm in greatest diameter * Patient \>18 years of age * Willing and able to sign informed consent
Exclusion criteria
* Patients with wound-related cellulitis * Patients with thick eschar at wound base post debridement * Patients with wounds located in an area not amenable to forming an air- tight seal * Ulcers due to inflammatory conditions such as pyodermagangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosislipoidicadiabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome * Patient has untreated osteomyelitis * Patient is allergic to wound care products * Patient wounds with exposed blood vessels not suitable for negative pressure therapy * Pregnant or pregnancy-suspected patients * Subject actively participating in other clinical trials that conflict with the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of complaints about device use and operation | 16 weeks |
Countries
United States
Outcome results
None listed