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

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ClinicalTrials.gov Identifier: NCT01417234
Recruitment Status : Unknown
Verified December 2012 by Spiracur, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 16, 2011
Last Update Posted : December 12, 2012
Sponsor:
Information provided by (Responsible Party):
Spiracur, Inc.

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.

Condition or disease Intervention/treatment
Trauma-related Wound Surgical Wound, Recent Device: SNaP® Wound Care System

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
Study Start Date : June 2011
Estimated Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Wound Closure [ Time Frame: 12 weeks ]
    Percent wound size reduction.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from exisiting investigator patient population.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417234


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 41955
Sponsors and Collaborators
Spiracur, Inc.

Responsible Party: Spiracur, Inc.
ClinicalTrials.gov Identifier: NCT01417234     History of Changes
Other Study ID Numbers: 102110
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Wounds and Injuries
Surgical Wound