NCT03632005

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: John Street · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Disease
• Spinal Cord Injury
• Spinal Degeneration
• Spinal Deformity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-18
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2018-08-15
• Last updated: 2018-08-15

Locations

1 site across 1 country: Canada