Spinal Cord Injury Clinical Trial
Official title:
A Prospective Randomized Clinical Trial Comparing Incisional Negative Pressure Wound Therapy to Conventional Sterile Dressing in Patients Undergoing Thoracolumbar Posterior Spine Surgery
NCT number | NCT03632005 |
Other study ID # | H13-02263 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 18, 2017 |
Est. completion date | August 2020 |
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.
Status | Recruiting |
Enrollment | 550 |
Est. completion date | August 2020 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
John Street | KCI USA, Inc., University of British Columbia Orthopaedics Research Excellence Fund |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 weeks post-op |
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