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

Primary Purpose

Metastatic Disease, Spinal Cord Injury, Spinal Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vacuum Assisted Closure
Sterile dressing
Sponsored by
John Street
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metastatic Disease focused on measuring Surgical Site Infection

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Sterile Dressing

Vacuum Assisted Closure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2018
Last Updated
August 13, 2018
Sponsor
John Street
Collaborators
3M, University of British Columbia Orthopaedics Research Excellence Fund
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1. Study Identification

Unique Protocol Identification Number
NCT03632005
Brief Title
Negative Pressure Wound Therapy vs. Sterile Dressing for Patients Undergoing Thoracolumbar Spine Surgery
Official Title
A Prospective Randomized Clinical Trial Comparing Incisional Negative Pressure Wound Therapy to Conventional Sterile Dressing in Patients Undergoing Thoracolumbar Posterior Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2017 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Street
Collaborators
3M, University of British Columbia Orthopaedics Research Excellence Fund

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Disease, Spinal Cord Injury, Spinal Degeneration, Spinal Deformity
Keywords
Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sterile Dressing
Arm Type
Other
Arm Description
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.
Arm Title
Vacuum Assisted Closure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vacuum Assisted Closure
Other Intervention Name(s)
Prevena™ System
Intervention Description
Patients will be randomized to receive either standard dressing changes or the Prevena™ System on the day of their operation.
Intervention Type
Other
Intervention Name(s)
Sterile dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
6 weeks post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Metastic tumor of the thoracic or lumbar spine (T1-S5), requiring instrumentation and decompression, with or without pre-operative radiation to surgical site Thoracolumbar degeneration or deformity (T1-S5) with index surgery >6 months prior, requiring revision surgery with additional instrumentation 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allan Aludino
Phone
604-875-4111
Ext
61689
Email
allan.aludino@vch.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Leilani Reichl
Phone
604-875-4111
Ext
62853
Email
leilani.reichl@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Street, MD,PhD,FRCSI
Organizational Affiliation
University of British Columbia & Vancouver General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allan Aludino
Phone
6048754111
Ext
61689
Email
allan.aludino@vch.ca
First Name & Middle Initial & Last Name & Degree
Leilani Reichl
Phone
6048754111
Ext
62853
Email
leilani.reichl@vch.ca
First Name & Middle Initial & Last Name & Degree
John Street, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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