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

Spinal Cord Injury Clinical Trial

Official title:

A Prospective Randomized Clinical Trial Comparing Incisional Negative Pressure Wound Therapy to Conventional Sterile Dressing in Patients Undergoing Thoracolumbar Posterior Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03632005
• Other study ID #: H13-02263
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2017
• Est. completion date: August 2020

Study information

• Verified date: August 2018
• Source: University of British Columbia
• Contact: Allan Aludino
• Phone: 604-875-4111
• Email: allan.aludino[@]vch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Disease
• Neoplasm Metastasis
• Spinal Cord Injuries
• Spinal Cord Injury
• Spinal Deformity
• Spinal Degeneration

Intervention

Device:
• Vacuum Assisted Closure
Patients will be randomized to receive either standard dressing changes or the Prevena™ System on the day of their operation.

Other:
• 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.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
John Street	KCI USA, Inc., University of British Columbia Orthopaedics Research Excellence Fund

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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