Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT03632005
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:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT03632005
Study Brief:
Protocol Section:
NCT03632005