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

Primary Purpose

Spine Surgery, Wounds Vac

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wound Vac
Standard Dressing
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spine Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Wound Vac

Standard Dressing

Arm Description

Wound vac

Standard Dressing

Outcomes

Primary Outcome Measures

Post operative infection requiring return to operating room

Secondary Outcome Measures

Full Information

First Posted
October 4, 2016
Last Updated
January 5, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02926924
Brief Title
Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients
Official Title
Prophylactic Application of an Incisional Wound Vac to Prevent Wound
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2011 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Surgery, Wounds Vac

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wound Vac
Arm Type
Active Comparator
Arm Description
Wound vac
Arm Title
Standard Dressing
Arm Type
Active Comparator
Arm Description
Standard Dressing
Intervention Type
Device
Intervention Name(s)
Wound Vac
Other Intervention Name(s)
Negative pressure therapy
Intervention Description
a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds and enhance healing of first and second degree burns.
Intervention Type
Other
Intervention Name(s)
Standard Dressing
Intervention Description
standard dressing with drain tube and bandage
Primary Outcome Measure Information:
Title
Post operative infection requiring return to operating room
Time Frame
6 weeks post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaimee Gauthier, BS
Phone
734-647-0050
Email
jaimeeg@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Patel, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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