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

NCT03632005 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2018-08-15

No results posted yet for this study

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.

Conditions

Interventions

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

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.

Sponsors & Collaborators

  • KCI USA, Inc

    collaborator INDUSTRY

  • University of British Columbia Orthopaedics Research Excellence Fund

    collaborator UNKNOWN

  • John Street

    lead OTHER

Principal Investigators

  • John Street, MD,PhD,FRCSI · University of British Columbia & Vancouver General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-18
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03632005 on ClinicalTrials.gov