Status:
COMPLETED
Incisional Negative Pressure Wound Therapy in Patients Undergoing Spine Surgery
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Surgical Site Infection
Eligibility:
All Genders
17+ years
Phase:
NA
Brief Summary
Introduction: Posterior post-operative spine wounds involving surgery at multiple levels are known to have higher rates of wound complications relative to other areas of the body. Instrumentation, rep...
Detailed Description
Patients with surgical site infection (SSI) of the spine have higher morbidity and mortality and higher costs of care. Hospital length of stay has been shown to be significantly longer, and readmissio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03820219
Start Date
July 15 2019
End Date
December 12 2020
Last Update
February 2 2023
Active Locations (1)
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1
Nova Scotia Health
Halifax, Nova Scotia (NS), Canada, B3L 4P1