Status:
COMPLETED
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
Lead Sponsor:
3M
Conditions:
Trauma-related Wound
Surgical Wound, Recent
Eligibility:
All Genders
18+ years
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 com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01417234
Start Date
June 1 2011
End Date
October 1 2012
Last Update
August 1 2022
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 41955