Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02954835
Previous Study | Return to List | Next Study

Negative Pressure Therapy for Groin 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: NCT02954835
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Englewood Hospital and Medical Center

Tracking Information
First Submitted Date  ICMJE November 2, 2016
First Posted Date  ICMJE November 3, 2016
Last Update Posted Date February 7, 2020
Study Start Date  ICMJE December 2016
Actual Primary Completion Date September 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
Infection rate [ Time Frame: 17 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Negative Pressure Therapy for Groin Wounds
Official Title  ICMJE Negative Pressure Therapy for Closed Groin Wounds in Patients Undergoing Vascular Surgery
Brief Summary The purpose of this study is to compare wound infection rates between negative pressure therapy (Prevena) and the traditional sterile dry dressing among patients undergoing vascular surgery involving groin incisions.
Detailed Description This is a prospective, investigator-initiated, post-market data collection study comparing wound infection rates among patients undergoing vascular surgery involving groin incisions. Patients will be randomized on the day of surgery to receive the traditional sterile dry dressing or Prevena. Patients with the traditional dressing will undergo dressing changes as per the standard protocol with the first dressing change at postoperative day 2 or 3, or at the discretion of the attending surgeon. The patients with Prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit. The Primary Objective of this study is to see if using negative pressure therapy decreases the rate of infection. The Secondary Objectives will include multivariate analysis to understand which patients may have a compounded benefit from Prevena (e.g. smokers, diabetics, and obese patients). The Prevena System is an FDA approved bandage and will be used in this study for on-label purposes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Wound Infection
Intervention  ICMJE
  • Device: Prevena
    Prevena is a sterile silver dressing. On top of the silver dressing is an adhesive plastic, which is connected to a therapy unit through a short length suction tube.
  • Device: Traditional Dressing
    Sterile gauze dressing secured by tape.
Study Arms  ICMJE
  • Active Comparator: Prevena
    Subjects randomized to the Prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit.
    Intervention: Device: Prevena
  • Active Comparator: Traditional Dressing
    Subjects randomized to the traditional dressing will undergo dressing changes as per the standard protocol with the first dressing change at postoperative day 2 or 3, or at the discretion of the attending surgeon.
    Intervention: Device: Traditional Dressing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2020)
2
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2016)
100
Actual Study Completion Date  ICMJE September 3, 2019
Actual Primary Completion Date September 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing vascular surgery with a groin incision.

Exclusion Criteria:

  • Allergy to silver.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02954835
Other Study ID Numbers  ICMJE E-16-679
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Englewood Hospital and Medical Center
Study Sponsor  ICMJE Englewood Hospital and Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Bernik, MD Englewood Hospital and Medical Center
PRS Account Englewood Hospital and Medical Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP