Phase
Condition
Neoplasm Metastasis
Spinal Cord Injuries
Metastatic Cancer
Treatment
N/AClinical Study ID
Ages > 17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patients who meet the following criteria are eligible for admissioninto 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 instrumentationand decompression, with or without pre-operative radiation to surgical site
Thoracolumbar degeneration or deformity (T1-S5) with index surgery >6 monthsprior, requiring revision surgery with additional instrumentation
Acute traumatic thoracolumbar (T1-L5) fracture(s) with neurological deficit (AISA-C), requiring instrumentation and decompression All study participants will remain in hospital for a minimum of 7 days post-op as perstandard of care. As a result, the full duration of application of the Prevena dressingwill take place in hospital.
Exclusion
Exclusion Criteria: patients who fulfill any of the following criteria are not eligible foradmission into the study:
Undergoing percutaneous surgery
Active Surgical Site Infection (SSI) or primary spinal column infection or distantsite infection (urinary tract, respiratory tract, etc.) at time of admission
Pregnancy The following are clinical scenarios that would mandate the patients' exclusion from finalanalysis:
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 (sixweeks), for causes other than primary (SSI) or secondary (dehiscence, seroma) studyendpoints
Study Design
Study Description
Connect with a study center
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9
CanadaActive - Recruiting
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