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

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ClinicalTrials.gov Identifier: NCT02926924
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : November 7, 2019
Sponsor:
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 ]


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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:

  • 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 ClinicalTrials.gov identifier (NCT number): NCT02926924


Contacts
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Contact: Jaimee Gauthier, BS 734-647-0050 jaimeeg@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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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
ClinicalTrials.gov 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