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

NCT ID: NCT02926924

Last Updated: 2025-04-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-01

Study Completion Date

2015-01-15

Brief Summary

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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

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Conditions

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Spine Surgery Wounds Vac

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Wound Vac

Wound vac

Group Type ACTIVE_COMPARATOR

Wound Vac

Intervention Type 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.

Standard Dressing

Standard Dressing

Group Type ACTIVE_COMPARATOR

Standard Dressing

Intervention Type OTHER

standard dressing with drain tube and bandage

Interventions

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Wound Vac

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

Intervention Type DEVICE

Standard Dressing

standard dressing with drain tube and bandage

Intervention Type OTHER

Other Intervention Names

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Negative pressure therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Rakesh Patel

Clinical Assistant Professor, Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rakesh Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00050885

Identifier Type: -

Identifier Source: org_study_id

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