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

NCT02926924 | Completed Results

• 1 other identifier: HUM00050885
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Surgery; Wounds Vac

Outcome Measures

Primary Outcomes (1)

• Count of Patients With Post Operative Infection

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

  6 weeks post surgery

Study Arms (2)

Wound Vac

ACTIVE COMPARATOR

Wound vac

Device: Wound Vac

Standard Dressing

ACTIVE COMPARATOR

Standard Dressing

Other: Standard Dressing

Interventions

Wound Vac DEVICE

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

Also known as: Negative pressure therapy

Wound Vac

Standard Dressing OTHER

standard dressing with drain tube and bandage

Standard Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Limitations and Caveats

This small study was intended to be a pilot. Without a larger population, results should not be seen as generalizable.

Results Point of Contact

• Title: Rakesh Patel
• Organization: University of Michigan

rakeshpa@med.umich.edu

734 615-2002

Study Officials

• Rakesh Patel, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Orthopaedic Surgery

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 6, 2016
• Study Start: August 1, 2011
• Primary Completion: January 15, 2015
• Study Completion: January 15, 2015
• Last Updated: April 11, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-03

Locations

US (1)