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

Trauma-related Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417234
• Other study ID #: 102110
• Status: Completed
• Start date: June 2011
• Est. completion date: October 2012

Study information

• Verified date: July 2022
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound
• Surgical Wound, Recent
• Trauma-related Wound
• Wounds and Injuries

Intervention

Device:
• SNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Closure	Percent of subjects with study wound deemed closed at 12 weeks; 1 wound is studied per participant	12 weeks
Secondary	Percent Wound Size Change	Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline)	Baseline and 4 weeks
Secondary	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
Secondary	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