Clinical Evaluation of the SNaP Wound Care System

Not Applicable

Withdrawn

• Conditions: Pressure Ulcers; Trauma Wounds; Venous Stasis Ulcers; Acute and Chronic Wounds; Diabetic Foot Ulcers
• Interventions: Device: SNaP Wound Care System

• Registration Number: NCT01113658
• Lead Sponsor: 3M

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-29
• Study First Posted: 2010-04-30
• Primary Completion: 2014-04
• Study Completion: 2014-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SNaP	SNaP Wound Care System	SNaP disposable, mechanically powered Negative Pressure Wound Therapy System

Primary Outcome Measures

Name	Time	Method
Frequency of complaints about device use and operation	16 weeks

Trial Locations

Locations (2)

San Francisco Center for Advanced Wound Care; 🇺🇸 Daly City, California, United States

The SF Center For Advanced Wound Care At; 🇺🇸 Daly City, California, United States