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OpenTrials
Completed

NCT Number: NCT02926924

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

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.

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Key information

Conditions

Spine Surgery Wounds Vac

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Negative pressure therapy

standard dressing

Other

standard dressing with drain tube and bandage

Primary outcomes

  1. Count of Patients With Post Operative Infection

    Time frame: 6 weeks post surgery

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Prophylactic Application of an Incisional Wound Vac to Prevent Wound

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2016
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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