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

Not Applicable

• Conditions: Spine Surgery; Wounds Vac
• Interventions: Device: Wound Vac; Other: Standard Dressing

• Registration Number: NCT02926924
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-01
• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-06
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-06
• Primary Completion: 2023-04-01
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wound Vac	Wound Vac	Wound vac
Standard Dressing	Standard Dressing	Standard Dressing

Primary Outcome Measures

Name	Time	Method
Post operative infection requiring return to operating room	6 weeks post surgery

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States