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Evaluation of a Novel Post-Surgical Dressing

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: NCT01831596
Recruitment Status : Terminated (The study was terminated by Spiracur. Efforts were made to contact the PI/study team members, but were unsuccessful.)
First Posted : April 15, 2013
Results First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.

Condition or disease Intervention/treatment Phase
Post Surgical Wound Device: ciSNaP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Novel Post-Surgical Dressing
Actual Study Start Date : November 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: ciSNaP Device: ciSNaP
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System




Primary Outcome Measures :
  1. Frequency of Complaints About Device Use and Operation [ Time Frame: 30 days ]
    Frequency of complaints about device use and operation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgically closed incision.
  • Subject is 18 years of age or older.
  • Subject consents to follow-up per protocol.
  • Willing and able to sign informed consent.

Exclusion Criteria:

  • Subject is allergic to wound care products used in this study.
  • Subject has wounds with exposed blood vessels not suitable for negative pressure therapy.
  • Pregnant or pregnancy-suspected subject.
  • Subject actively participating in other clinical trials that conflict with the current study.
  • Subject is unable or unwilling to comply with protocol requirements.

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): NCT01831596


Locations
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United States, California
El Camino Hospital
Mountain View, California, United States, 94040
Sponsors and Collaborators
KCI USA, Inc.
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Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT01831596    
Other Study ID Numbers: 030110
First Posted: April 15, 2013    Key Record Dates
Results First Posted: September 28, 2020
Last Update Posted: September 28, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries