Negative Pressure Wound Therapy vs. Sterile Dressing for Patients Undergoing Thoracolumbar Spine Surgery

John Street

Status: Unknown

Conditions: Spinal Degeneration; Metastatic Disease; Spinal Deformity; Spinal Cord Injury

Treatments: Device: Vacuum Assisted Closure; Other: Sterile dressing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03632005

H13-02263

Details and patient eligibility

About

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.

Full description

Certain risk factors have been identified in patients that may lead to poor wound healing or infection. Many things have been tried to decrease this risk (more antibiotics, different types of stitches, etc) but very few have been shown to be of any significant benefit.

The use of a special vacuum dressing called the Prevena™ System, which has received approval from Health Canada for the management of closed surgical incisions, has been shown to be of some benefit in hip surgery where wounds are identified as being "at risk." Vacuum dressings have been used with great success in patients with open wounds and have resulted in fewer infections and wound related complications. It is thought that if vacuum dressings can be used in the treatment of existing wounds, then maybe they can be used preventatively before there is a problem with the wound.

Standard wound care after spine surgery involves a dressing that seals the wound for 72 hours after surgery and is then changed on a daily basis until the surgical sutures or staples are ready to be removed. This has been routine for many years.

The purpose of this study is to see if using a vacuum dressing (Prevena™ System) will decrease the number of infections and/or clinic and hospital visits for wound related issues compared to using a standard dressing on wounds in patients with risk factors for early wound infection.

Enrollment: 550 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

Sterile Dressing

Other group

Description:

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.

Treatment:

Other: Sterile dressing

Vacuum Assisted Closure

Active Comparator group

Description:

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.

Treatment:

Device: Vacuum Assisted Closure