Clinical Evaluation of the SNaP Wound Care System

NCT01113658 | Withdrawn

• 1 other identifier: SNaP-113009
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Frequency of complaints about device use and operation

  16 weeks

Study Arms (1)

SNaP

EXPERIMENTAL

SNaP disposable, mechanically powered Negative Pressure Wound Therapy System

Device: SNaP Wound Care System

Interventions

SNaP Wound Care System DEVICE

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.

Also known as: Spiracur SNaP Wound Care System, SNaP, The SNaP System

SNaP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Wound \< 10 cm in greatest diameter
• Patient \>18 years of age
• Willing and able to sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• 3M: lead

Study Sites (2)

San Francisco Center for Advanced Wound Care

Daly City, California, 94015, United States

Location

The SF Center For Advanced Wound Care At

Daly City, California, 94015, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Kristine K Nemes, DPM

  Seton Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: April 30, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

US (2)