Back to resultsClinical Evaluation of the SNaP Wound Care System
Primary Purpose
Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SNaP Wound Care System
Sponsored by
About this trial
This is an interventional treatment trial for Acute and Chronic Wounds focused on measuring negative pressure wound therapy, NPWT, Spiracur, SNaP Wound Care System
Eligibility Criteria
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
Sites / Locations
- San Francisco Center for Advanced Wound Care
- The SF Center For Advanced Wound Care At
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SNaP
Arm Description
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
Outcomes
Primary Outcome Measures
Frequency of complaints about device use and operation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01113658
Brief Title
Clinical Evaluation of the SNaP Wound Care System
Official Title
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.
Study Start Date
March 2010 (Anticipated)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds, Diabetic Foot Ulcers, Venous Stasis Ulcers
Keywords
negative pressure wound therapy, NPWT, Spiracur, SNaP Wound Care System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SNaP
Arm Type
Experimental
Arm Description
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
Intervention Type
Device
Intervention Name(s)
SNaP Wound Care System
Other Intervention Name(s)
Spiracur SNaP Wound Care System, SNaP, The SNaP System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of complaints about device use and operation
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine K Nemes, DPM
Organizational Affiliation
Seton Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Center for Advanced Wound Care
City
Daly City
State/Province
California
ZIP/Postal Code
94015
Country
United States
Facility Name
The SF Center For Advanced Wound Care At
City
Daly City
State/Province
California
ZIP/Postal Code
94015
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of the SNaP Wound Care System
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