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Prospective Observation of Wound Healing With Prevena Incision Management System

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: NCT01704924
Recruitment Status : Withdrawn (No study subjects enrolled, Investigator decided to cancel the project)
First Posted : October 12, 2012
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gregory R. Evans, University of California, Irvine

Brief Summary:
This study aims to assess the quality of wound healing in abdominal scars with and without the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved wound healing with less swelling, bruising, and inflammation, as well as less potential for infection, seroma, and dehiscence.

Condition or disease Intervention/treatment Phase
Scarring Device: Prevena Procedure: Standard of Care Dressing Not Applicable

Detailed Description:
The quality of wound healing can be of the utmost importance for patients undergoing large abdominal surgery. Incisional negative pressure wound therapy has been observed to decrease seroma and infection rates in high risk patients. This study aims to quantify the effect, if any, that negative pressure wound therapy has on closed incisions. The technology may provide benefits even in lower risk patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Observation of Wound Healing With Prevena Incision Management System
Actual Study Start Date : October 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Prevena
Incision with prevena device overlying
Device: Prevena
Device will be applied at end of procedure over closed incision

Active Comparator: Standard of Care dressing
Prevena device is not used
Procedure: Standard of Care Dressing
Dressing applied as Standard of Care




Primary Outcome Measures :
  1. Scarring [ Time Frame: 0-6 months ]
    Assess quality of scar: hypertrophy, hyperpigmentation, etc



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:   Yes
Criteria

Inclusion Criteria:

  • abdominal procedure with incision >20cm
  • must be >18 years of age

Exclusion Criteria:

  • <18 years of age
  • history of allergy or reaction to adhesives
  • pregnant or anticipated pregnancy within 6 months

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): NCT01704924


Locations
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United States, California
University of California at Irvine
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Gregory Evans, MD The University of California Irvine
Additional Information:
Publications:
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Responsible Party: Gregory R. Evans, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01704924    
Other Study ID Numbers: KCI-2011-8268
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Keywords provided by Gregory R. Evans, University of California, Irvine:
Prevena
negative pressure wound therapy
Incisional wound vac
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes