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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: 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
Other: Standard Dressing
standard dressing with drain tube and bandage
- Post operative infection requiring return to operating room [ Time Frame: 6 weeks post surgery ]
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
|Contact: Jaimee Gauthier, BSemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Rakesh Patel, MD||University of Michigan|