Clinical Evaluation of the SNaP Wound Care System

3M Company

Status: Withdrawn

Conditions: Acute and Chronic Wounds; Trauma Wounds; Diabetic Foot Ulcers; Pressure Ulcers; Venous Stasis Ulcers

Treatments: Device: SNaP Wound Care System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01113658

SNaP-113009

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

SNaP

Experimental group

Description:

SNaP disposable, mechanically powered Negative Pressure Wound Therapy System

Treatment:

Device: SNaP Wound Care System