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Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02926924
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : November 7, 2019
Information provided by (Responsible Party):
Rakesh Patel, University of Michigan

Brief Summary:

This is a prospective randomized study evaluating the use of a prophylactic incision wound vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a BMI>35. Patients are randomized in the operating room to normal postoperative dressing vs. vac dressing. The vac dressing would be left on for 72 hours postoperatively. In the interim, the patients' postoperative care can proceed as usual. Our primary outcomes will be antibiotics or return trip needed to the operating room for wound related complications.

The patients only intervention would be the application of an incisional wound vac. The will be no change in the patients postoperative protocol otherwise. This procedure is noninvasive.

Condition or disease Intervention/treatment Phase
Spine Surgery Wounds Vac Device: Wound Vac Other: Standard Dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Application of an Incisional Wound Vac to Prevent Wound
Study Start Date : August 2011
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Wound Vac
Wound vac
Device: Wound Vac
a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds and enhance healing of first and second degree burns.
Other Name: Negative pressure therapy

Active Comparator: Standard Dressing
Standard Dressing
Other: Standard Dressing
standard dressing with drain tube and bandage

Primary Outcome Measures :
  1. Post operative infection requiring return to operating room [ Time Frame: 6 weeks post surgery ]

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

Inclusion Criteria:

  • Be scheduled to have posterior spine surgery (inpatient procedures only).
  • Have a BMI greater than or equal to 35.

Exclusion Criteria:

  • BMI less than 35
  • Previous spine infection
  • Intraoperative dural tear

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 identifier (NCT number): NCT02926924

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Contact: Jaimee Gauthier, BS 734-647-0050

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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Principal Investigator: Rakesh Patel, MD University of Michigan

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Responsible Party: Rakesh Patel, Clinical Assistant Professor, Orthopaedic Surgery, University of Michigan Identifier: NCT02926924     History of Changes
Other Study ID Numbers: HUM00050885
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Wounds and Injuries