Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Spiracur, Inc..
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
First received: August 12, 2011
Last updated: December 11, 2012
Last verified: December 2012
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.
Surgical Wound, Recent
Device: SNaP® Wound Care System
||Observational Model: Cohort
Time Perspective: Prospective
||Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||February 2013 (Final data collection date for primary outcome measure)
SNaP® Wound Care System
Device: SNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Study population will be selected from exisiting investigator patient population.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417234
|Cleveland, Ohio, United States, 41955 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 12, 2011
||December 11, 2012
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 26, 2015