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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01417234
Recruitment Status : Completed
First Posted : August 16, 2011
Results First Posted : November 6, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
KCI USA, 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

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Study Type : Observational
Actual 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
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


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 of subjects with study wound deemed closed at 12 weeks

    1 wound is studied per participant



Secondary Outcome Measures :
  1. Percent Wound Size Change [ Time Frame: Baseline and 4 weeks ]
    Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline)

  2. Percent Wound Size Change [ Time Frame: 4 weeks and 8 weeks ]
    Percent change in wound size from week 4 to week 8 (Week 8 - Week 4 / Week 4)

  3. Percent Wound Size Change [ Time Frame: 8 weeks and 12 weeks ]
    Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 41955
Sponsors and Collaborators
KCI USA, Inc.
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Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT01417234    
Other Study ID Numbers: 102110
First Posted: August 16, 2011    Key Record Dates
Results First Posted: November 6, 2020
Last Update Posted: November 6, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Wounds and Injuries
Surgical Wound