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

University of Michigan

Status: Completed

Conditions: Spine Surgery; Wounds Vac

Treatments: Device: Wound Vac; Other: Standard Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT02926924

HUM00050885

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Wound Vac

Active Comparator group

Description:

Wound vac

Treatment:

Device: Wound Vac

Standard Dressing

Active Comparator group

Description:

Standard Dressing

Treatment:

Other: Standard Dressing