Recruiting

Negative Pressure Wound Therapy vs. Sterile Dressing

Sponsor:

John Street

Code:

NCT03632005

Conditions

Metastatic Disease

Spinal Cord Injury

Spinal Degeneration

Spinal Deformity

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

Interventions

Vacuum Assisted Closure

Sterile dressing

Study Details

Brief summary:

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.

Conditions

Metastatic Disease

Spinal Cord Injury

Spinal Degeneration

Spinal Deformity

Study ID

NCT03632005

Start date

Mar 18, 2017

Status verified date

Aug, 2018

Completion date

Aug, 2020

Anticipated

Primary completion date

Aug, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Sterile Dressing

Standard of care treatment - 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.

active comparator: Vacuum Assisted Closure

The Prevena™ System, a type of vacuum assisted closure, 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.

Interventions

Vacuum Assisted Closure

Patients will be randomized to receive either standard dressing changes or the Prevena™ System on the day of their operation.

Sterile dressing

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.

Primary outcome measure

  • 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 [ Time Frame: 6 weeks post-op ]

Central Contacts and Locations

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Principal Investigator:

John Street, MD, PhD

More Information

Sponsor

John Street

Last update posted

Aug 15, 2018

Last verified

Aug, 2018

Keywords

  • Surgical Site Infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by John Street on 2018-08-15.