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

University of Michigan68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Spine Surgery Wounds Vac

Interventions

a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds and enhance healing of first and second degree burns.

Standard DressingOTHER

standard dressing with drain tube and bandage

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Count of Patients With Post Operative Infection

Count of Patients with Post operative infection requiring return to operating room or prolonged treatment of antibiotics

Time frame: 6 weeks post surgery

Data from ClinicalTrials.gov

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