Effect of Intra-wound Vancomycin for Spinal Surgery: A Systematic Review and Meta-analysis.
Lun-Li Xie, Jun Zhu, Mao-Sheng Yang...
https://pubmed.ncbi.nlm.nih.gov/29178308Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID04825522
The Effect of Intrawound Vancomycin Powder in Spine Surgery: A Prospective Randomized Controlled Trial
Led by Windsor-Essex Compassionate Care Community · Updated on 2024-04-23
1643
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Windsor-Essex Compassionate Care Community
Lead Sponsor
C
Cairo University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Postoperative wound infections after spinal surgeries are a serious concern due to their high occurrence, increased healthcare costs, longer hospital stays, and reduced quality of life. Various methods have been used to prevent these infections, including betadine irrigation, vacuum-assisted closure, and intra-wound vancomycin powder. This trial aims to evaluate the effect of applying intrawound vancomycin powder during spinal surgery to reduce the rate of post-surgical infections. Participants will be randomly assigned to one of two groups: one group will receive intrawound vancomycin powder during surgery, while the control group will not receive this intervention. The amount of vancomycin powder applied depends on the number of surgical levels involved, ranging from 500 mg to 2 grams. All patients will receive standard systemic antibiotic prophylaxis, and the study will use a single-blind design where patients are unaware of their group assignment. Participants will be monitored for 12 weeks after surgery to detect wound infections and other complications, including those related to vancomycin use. Data collected include patient demographics, comorbidities, surgical details, and infection outcomes. The primary outcome is the rate of infection within three months, and secondary outcomes include other complications during this period. The study will also record cultured organisms and treatments administered for infections.
CONDITIONS
Brief Title
The Effect of Intrawound Vancomycin Powder in Spine Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients requiring surgery due to any spine disease.
- Age 18 years or older.
You will not qualify if you...
- Previous history of infections at the spine surgical site.
- Biopsy procedure.
- Postoperative follow-up time less than 12 weeks.
- Allergy to vancomycin.
- Age under 18 years.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Day of surgery
Participants undergo spine surgery during which intrawound vancomycin powder may be applied before wound closure as part of the randomized intervention. All participants receive standard systemic antibiotic prophylaxis.
1 surgical procedure visit (in-person)
Follow-up
Duration - 12 weeks
Participants are monitored for wound infections and other complications for 12 weeks after surgery.
Approximately 3 follow-up visits over 12 weeks (in-person)
Trial Site Locations
Total: 2 locations
1
Windsor Regional Hospital - Ouellette
Windsor, Ontario, Canada, N9A 1E1
Actively Recruiting
2
Cairo University Hospitals
Cairo, Egypt, 11562
Actively Recruiting
Loading map...
Research Team
M
Mohamed Soliman, MSc, MD
A
Abdalla Shamisa, FRCSC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Reducing surgical site infection in spinal surgery with betadine irrigation and intrawound vancomycin powder.
Marko Tomov, Lance Mitsunaga, Blythe Durbin-Johnson...
https://pubmed.ncbi.nlm.nih.gov/25608241Intrawound vancomycin to prevent infections after spine surgery: a systematic review and meta-analysis.
Nathan Evaniew, Moin Khan, Brian Drew...
https://pubmed.ncbi.nlm.nih.gov/24838506Is Intraoperative Local Vancomycin Powder the Answer to Surgical Site Infections in Spine Surgery?
Hwee Weng Dennis Hey, Desmond Wei Thiam, Zhi Seng Darren Koh...
https://pubmed.ncbi.nlm.nih.gov/28207669Reduced surgical site infections in patients undergoing posterior spinal stabilization of traumatic injuries using vancomycin powder.
Kevin R O'Neill, Jason G Smith, Amir M Abtahi...
https://pubmed.ncbi.nlm.nih.gov/21600853