Incisional Negative Pressure Wound Therapy in Patients Undergoing Spine Surgery
Surgical Site Infection
About this trial
This is an interventional treatment trial for Surgical Site Infection focused on measuring spine, surgical dressing, negative pressure therapy, surgical infection
Eligibility Criteria
Inclusion Criteria:
- Capable of and agree to consent to randomization
- Require spine surgery with a posterior midline incision that involves the thoracic, lumbar and/or sacral spine
Be one of the following clinical presentation groups:
- Metastatic Tumor of the Thoracic or Lumbar spine (T1-S5), requiring instrumentation and decompression, with or without pre-operative site radiation
- Revisions Surgery requiring additional instrumentation or revision instrumentation, for thoracolumbar degeneration or deformity (T1-S1), index surgery >6 months prior
- Acute Traumatic Thoracolumbar (T1-L5) fracture(s) with neurological deficit (AIS A-C), requiring instrumentation and decompression
Exclusion Criteria:
Initially:
- Undergoing percutaneous surgery
- Active Surgical Site infection or Primary Spinal Column infection or Distant Site Infection (urinary tract, respiratory tract, etc.)
Subsequently:
- Failure to complete the 6-week clinical follow-up (Loss to Follow Up)
- Second surgery, at the same anatomical site, required during study time period (six weeks), for causes other than primary (SSI) or secondary (Dehiscence, Seroma) study endpoints.
Sites / Locations
- Nova Scotia Health
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Standard sterile wound dressing
Prevena™ system
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 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, until it is removed at Post-Operative Day 7.