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

NCT03632005 | Unknown

• 1 other identifier: H13-02263
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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

Keywords

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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

  Based on visual inspection of the surgical site, a 'Wound Inspection \& Dressing Utilization' case report form will be completed by a clinician, concluding at Week 6 post-op, to assess for the presence of SSI.

  6 weeks post-op

Study Arms (2)

Sterile Dressing

OTHER

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.

Other: Sterile dressing

Vacuum Assisted Closure

ACTIVE COMPARATOR

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.

Device: Vacuum Assisted Closure

Interventions

Vacuum Assisted Closure DEVICE

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

Also known as: Prevena™ System

Vacuum Assisted Closure

Sterile dressing OTHER

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.

Sterile Dressing

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Metastic tumor of the thoracic or lumbar spine (T1-S5), requiring instrumentation and decompression, with or without pre-operative radiation to surgical site
• Thoracolumbar degeneration or deformity (T1-S5) with index surgery \>6 months prior, requiring revision surgery with additional instrumentation
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• John Street: lead
• KCI USA, Inc: collaborator
• University of British Columbia Orthopaedics Research Excellence Fund: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Spinal Cord Injuries; Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Wound Infection; Infections; Postoperative Complications

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• John Street, MD,PhD,FRCSI

  University of British Columbia & Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan Aludino

CONTACT

604-875-4111; allan.aludino@vch.ca

Leilani Reichl

CONTACT

604-875-4111; leilani.reichl@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 15, 2018
• Study Start: March 18, 2017
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)