Negative Pressure Wound Therapy vs. Sterile Dressing for Patients Undergoing Thoracolumbar Spine Surgery

August 13, 2018 updated by: John Street

A Prospective Randomized Clinical Trial Comparing Incisional Negative Pressure Wound Therapy to Conventional Sterile Dressing in Patients Undergoing Thoracolumbar Posterior Spine Surgery

The purpose of this study is to determine if the use of the Prevena™ System decreases the rate of subcutaneous seroma, superficial wound dehiscence and infection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Certain risk factors have been identified in patients that may lead to poor wound healing or infection. Many things have been tried to decrease this risk (more antibiotics, different types of stitches, etc) but very few have been shown to be of any significant benefit.

The use of a special vacuum dressing called the Prevena™ System, which has received approval from Health Canada for the management of closed surgical incisions, has been shown to be of some benefit in hip surgery where wounds are identified as being "at risk." Vacuum dressings have been used with great success in patients with open wounds and have resulted in fewer infections and wound related complications. It is thought that if vacuum dressings can be used in the treatment of existing wounds, then maybe they can be used preventatively before there is a problem with the wound.

Standard wound care after spine surgery involves a dressing that seals the wound for 72 hours after surgery and is then changed on a daily basis until the surgical sutures or staples are ready to be removed. This has been routine for many years.

The purpose of this study is to see if using a vacuum dressing (Prevena™ System) will decrease the number of infections and/or clinic and hospital visits for wound related issues compared to using a standard dressing on wounds in patients with risk factors for early wound infection.

Study Type

Interventional

Enrollment (Anticipated)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Street, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Patients who meet the following criteria are eligible for admission into the study:

  • Require spine surgery with a posterior midline incision that involves the thoracic, lumbar and/or sacral spine
  • Capable of and agree to consent and randomization

  • Be in one of the following clinical presentation groups:

    1. Metastic tumor of the thoracic or lumbar spine (T1-S5), requiring instrumentation and decompression, with or without pre-operative radiation to surgical site
    2. Thoracolumbar degeneration or deformity (T1-S5) with index surgery >6 months prior, requiring revision surgery with additional instrumentation
    3. Acute traumatic thoracolumbar (T1-L5) fracture(s) with neurological deficit (AIS A-C), requiring instrumentation and decompression

All study participants will remain in hospital for a minimum of 7 days post-op as per standard of care. As a result, the full duration of application of the Prevena dressing will take place in hospital.

Exclusion Criteria: patients who fulfill any of the following criteria are not eligible for admission into the study:

  • Undergoing percutaneous surgery
  • Active Surgical Site Infection (SSI) or primary spinal column infection or distant site infection (urinary tract, respiratory tract, etc.) at time of admission
  • Pregnancy

The following are clinical scenarios that would mandate the patients' exclusion from final analysis:

  • Failure to complete the 6-week clinical follow-up (Lost to Follow Up)
  • Second surgery required, at the same anatomical site, during study time period (six weeks), for causes other than primary (SSI) or secondary (dehiscence, seroma) study endpoints

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sterile Dressing
Standard of care treatment - Standard wound care involves the application of an occlusive dressing in the operating room, a dressing change on Post-operative Day 3 and then dressing changes as needed until suture/staple removal on Post-operative Day 14.
Other: Sterile dressing
Standard wound care involves the application of an occlusive dressing in the operating room, a dressing change on Post-operative Day 3 and then dressing changes as needed until suture/staple removal on Post-operative Day 14.
Active Comparator: Vacuum Assisted Closure
The Prevena™ System, a type of vacuum assisted closure, is indicated for use over clean, closed incisions that continue to drain following sutured or stapled closure. It acts by removing exudate, helping hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment.
Device: Vacuum Assisted Closure
Patients will be randomized to receive either standard dressing changes or the Prevena™ System on the day of their operation.
Other Names:
  • Prevena™ System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute, post-operative surgical site infection (SSI) following thoracolumbar spinal surgery for a metastatic tumor, revision requiring additional instrumentation or acute traumatic spinal cord injury
Time Frame: 6 weeks post-op
Based on visual inspection of the surgical site, a 'Wound Inspection & Dressing Utilization' case report form will be completed by a clinician, concluding at Week 6 post-op, to assess for the presence of SSI.
6 weeks post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Street

Collaborators

3M
University of British Columbia Orthopaedics Research Excellence Fund

Investigators

  • Principal Investigator: John Street, MD,PhD,FRCSI, University of British Columbia & Vancouver General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2017

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-02263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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