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NCT02926924 Clinical Trial

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

Spine Surgery Clinical Trial

Official title:
Prophylactic Application of an Incisional Wound Vac to Prevent Wound

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02926924
Other study ID # HUM00050885
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2011
Est. completion date April 2023

Study information
Verified date January 2022
Source University of Michigan
Contact Jaimee Gauthier, BS
Phone 734-647-0050
Email jaimeeg@med.umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date April 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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:
• Standard Dressing
standard dressing with drain tube and bandage

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post operative infection requiring return to operating room 6 weeks post surgery
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