Clinical Evaluation of the SNaP Wound Care System

Diabetic Foot Ulcers Clinical Trial

Official title:

Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01113658
• Other study ID #: SNaP-113009
• Status: Withdrawn
• Phase: N/A
• Start date: March 2010
• Est. completion date: August 2014

Study information

• Verified date: July 2022
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute and Chronic Wounds
• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Pressure Ulcer
• Pressure Ulcers
• Trauma Wounds
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcers
• Wounds and Injuries

Intervention

Device:
• SNaP 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.

Locations

Country	Name	City	State
United States	San Francisco Center for Advanced Wound Care	Daly City	California
United States	The SF Center For Advanced Wound Care At	Daly City	California

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of complaints about device use and operation		16 weeks