NCT01113658WithdrawnNot Applicable
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- 3M
- Locations
- 4
- Primary Endpoint
- Frequency of complaints about device use and operation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Frequency of complaints about device use and operation
Time Frame: 16 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
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