NCT01113658

Clinical Evaluation of the SNaP Wound Care System

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: 3M · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-04-01
• Completion: 2014-08-01
• First posted: 2010-04-30
• Last updated: 2022-08-01

Locations

2 sites across 1 country: United States