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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spiracur, Inc.
ClinicalTrials.gov Identifier:
NCT01417234
First received: August 12, 2011
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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 Intervention
Trauma-related Wound
Surgical Wound, Recent
Device: SNaP® Wound Care System

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Spiracur, Inc.:

Primary Outcome Measures:
  • Wound Closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent wound size reduction.


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SNaP® Wound Care System Device: SNaP® Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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

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

No publications provided

Responsible Party: Spiracur, Inc.
ClinicalTrials.gov Identifier: NCT01417234     History of Changes
Other Study ID Numbers: 102110
Study First Received: August 12, 2011
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014