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Negative Pressure Wound Therapy to Reduce Surgical Site Infection

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ClinicalTrials.gov Identifier: NCT01905397
Recruitment Status : Recruiting
First Posted : July 23, 2013
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Kinetic Concepts, Inc.
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE July 18, 2013
First Posted Date  ICMJE July 23, 2013
Last Update Posted Date September 6, 2019
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
Incidence of Surgical Site Infection [ Time Frame: 30 days post-surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01905397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
  • Characterization of surgical site infection [ Time Frame: 30 days post-surgery ]
    Characterize the incidence of SSI as superficial incisional, deep incisional, and organ/space as defined by The American College of Surgeons NSQIP (National Surgical Quality Improvement Program) guidelines.
  • Length of hospital stay [ Time Frame: 30 days post-surgery ]
    Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Negative Pressure Wound Therapy to Reduce Surgical Site Infection
Official Title  ICMJE Evaluation of Negative Pressure Wound Therapy for Reduction of Postoperative Surgical Site Infection in Patients Undergoing Colorectal and Hepatopancreatobiliary Surgery
Brief Summary The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at the first clinic visit after surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Patients Undergoing Hepatopancreatobiliary Surgery
Intervention  ICMJE
  • Device: Conventional wound therapy
    Sterile bandages and wound coverings
  • Device: Negative pressure wound therapy
    The Prevena Incision Management System covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump may be used with the Prevena dressings as well in some situations to achieve negative pressure.
    Other Name: Prevena Incision Management System; ActiVAC
Study Arms  ICMJE
  • Active Comparator: Negative Pressure Wound Therapy
    The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure
    Intervention: Device: Negative pressure wound therapy
  • Active Comparator: Conventional wound therapy
    Traditional wound therapy (sterile bandages and dressing)
    Intervention: Device: Conventional wound therapy
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2017)
135
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2013)
126
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female and male patients 18 years of age or older
  • Scheduled for an elective surgery in either open CRS or open HPBS. This includes, but is not limited to: ileocecectomy, right hemicolectomy, extended right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoidectomy, proctectomy, low anterior resection, or abdominoperineal resection gastrectomy, hepatectomy, bile duct reconstruction, duodenectomy, pancreatectomy, pancreaticoduodenectomy, or pancreatic duct reconstruction

Exclusion Criteria:

  • The need for emergency surgery.
  • The need for use of only laparoscopic surgery.
  • Presence of bowel obstruction, strangulation, peritonitis or perforation.
  • The presence of local or systemic infection preoperatively.
  • ASA class ≥4.
  • Inability to provide informed consent and authorization.
  • Known allergy or hypersensitivity to silver.
  • Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study.
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: Emily Bolch 919-668-6359 emily.bolch@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01905397
Other Study ID Numbers  ICMJE Pro00045975
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Kinetic Concepts, Inc.
Investigators  ICMJE
Principal Investigator: Trey Blazer, MD Duke University
PRS Account Duke University
Verification Date September 2019

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