Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds

The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.

Study Overview

• Status: Completed
• Conditions: Surgical Wound, Recent; Trauma-related Wound
• Intervention / Treatment: Device: SNaP® Wound Care System

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 41955
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population will be selected from exisiting investigator patient population.

Description

Inclusion Criteria:

• Trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities
• Wound < 16 cm in greatest diameter
• Subject ≥ 18 years of age
• Exudate < 25 ml/ day (estimate)
• Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study
• Subject is willing and able to sign informed consent

Exclusion Criteria:

• Wound > 45 days old
• Wound-related cellulitis
• Wound located in an area not amenable to forming an air-tight seal
• Subject has untreated osteomyelitis
• Subject is allergic to wound care products
• Wound has exposed blood vessels not suitable for negative pressure therapy
• Subject is pregnant
• Subject is actively participating in other clinical trials that conflict with current study
• Subject has fistulas

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SNaP® Wound Care System	Device: SNaP® Wound Care System; Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Closure	Percent of subjects with study wound deemed closed at 12 weeks 1 wound is studied per participant	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Wound Size Change	Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline)	Baseline and 4 weeks
Percent Wound Size Change	Percent change in wound size from week 4 to week 8 (Week 8 - Week 4 / Week 4)	4 weeks and 8 weeks
Percent Wound Size Change	Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks)	8 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: 3M

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: August 12, 2011
• First Submitted That Met QC Criteria: August 12, 2011
• First Posted (Estimate): August 16, 2011

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 102110