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

Completed

• Conditions: Surgical Wound, Recent; Trauma-related Wound
• Interventions: Device: SNaP® Wound Care System

• Registration Number: NCT01417234
• Lead Sponsor: 3M

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-12
• Study First Posted: 2011-08-16
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2020-09-16
• Results First Submitted QC: 2020-10-15
• Results First Posted: 2020-11-06
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SNaP® Wound Care System	SNaP® Wound Care System	-

Primary Outcome Measures

Name	Time	Method
Wound Closure	12 weeks	Percent of subjects with study wound deemed closed at 12 weeks; 1 wound is studied per participant

Secondary Outcome Measures

Name	Time	Method
Percent Wound Size Change	8 weeks and 12 weeks	Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks)

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States