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Negative Pressure Wound Therapy to Reduce Surgical Site Infection

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ClinicalTrials.gov Identifier: NCT01905397
Recruitment Status : Suspended (Pending approval to re-open study and add additional subjects)
First Posted : July 23, 2013
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Kinetic Concepts, Inc.
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Patients Undergoing Hepatopancreatobiliary Surgery Device: Conventional wound therapy Device: Negative pressure wound therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Negative Pressure Wound Therapy for Reduction of Postoperative Surgical Site Infection in Patients Undergoing Colorectal and Hepatopancreatobiliary Surgery
Study Start Date : October 2013
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

Active Comparator: Conventional wound therapy
Traditional wound therapy (sterile bandages and dressing)
Device: Conventional wound therapy
Sterile bandages and wound coverings




Primary Outcome Measures :
  1. Incidence of Surgical Site Infection [ Time Frame: 30 days post-surgery ]

Secondary Outcome Measures :
  1. 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.

  2. 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.



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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:

  • 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.

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): NCT01905397


Locations
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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46223
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Kinetic Concepts, Inc.
Investigators
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Principal Investigator: Trey Blazer, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01905397     History of Changes
Other Study ID Numbers: Pro00045975
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Surgical Wound Infection
Infection
Wound Infection
Postoperative Complications
Pathologic Processes