RecruitingPhase 4NCT04825522

The Effect of Intrawound Vancomycin Powder in Spine Surgery

The Effect of Intrawound Vancomycin Powder in Spine Surgery: A Prospective Randomized Controlled Trial


Sponsor

Windsor-Essex Compassionate Care Community

Enrollment

1,643 participants

Start Date

Mar 27, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Problem: Postoperative wound infection following various spinal surgeries is a serious complication. The incidence of post-surgical wounds in spine surgery is high, and various researchers have reported different infection rates. In addition, increased healthcare costs, prolonged lengths of stay in hospital, and reduced quality of life as a result of surgical site infections (SSI) are also major concerns. Several methods for avoiding SSI, such as betadine irrigation, vacuum-assisted closure, and intra-wound vancomycin powder, have been used to reduce the rate of wound infection in spine surgery. Use of local vancomycin has been popular because of its protective effects and lower cost. According to some reports, prophylactic administration of intra-wound vancomycin powder before wound closure is an effective method for decreasing postoperative wound infection rates; however, other studies have revealed a non-significant effect of intra-wound vancomycin use for decreasing the postsurgical wound infection rate. Solution: Therefore, the investigators will prospectively randomize all various types of spinal surgeries to patients who will receive intrawound vancomycin powder and control group who will not receive the powder and to see it's effect in reducing the post-surgical infection.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether applying vancomycin powder — an antibiotic — directly into the surgical wound during spine surgery reduces the risk of post-operative spinal infections. Spinal infections after surgery are rare but serious and can be very difficult to treat. Some surgeons already use this technique, but evidence from a large organized study is still limited. This study collects outcome data from patients across multiple surgical centers to better understand how effective and safe this approach is. This is a registry/observational study — there is no randomization. Patients who are already receiving intrawound vancomycin as part of their surgeon's standard practice, and those who are not, will both be enrolled and their infection rates compared. You may be eligible if: - You are 18 years of age or older - You are scheduled for any type of spine surgery - You will be followed up for at least 12 weeks after surgery You may NOT be eligible if: - You have had a prior infection at the same surgical site - You are having only a biopsy procedure - You are allergic to vancomycin - You are under 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVancomycin

During spinal surgery, participants will receive intrawound vancomycin powder in their wound before closure.


Locations(2)

Windsor Regional Hospital - Ouellette

Windsor, Ontario, Canada

Cairo University Hospitals

Cairo, Egypt

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04825522


Related Trials