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/25608241/Actively Recruiting
Led by Windsor-Essex Compassionate Care Community · Updated on 2024-04-23
1643
Participants Needed
2
Research Sites
N/A
Total Duration
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
The Effect of Intrawound Vancomycin Powder in Spine Surgery
M
Mohamed Soliman, MSc, MD
A
Abdalla Shamisa, FRCSC
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
Windsor-Essex Compassionate Care Community
Lead Sponsor
Cairo University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
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)
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)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Marko Tomov, Lance Mitsunaga, Blythe Durbin-Johnson...
https://pubmed.ncbi.nlm.nih.gov/25608241/Lun-Li Xie, Jun Zhu, Mao-Sheng Yang...
https://pubmed.ncbi.nlm.nih.gov/29178308/Hwee Weng Dennis Hey, Desmond Wei Thiam, Zhi Seng Darren Koh...
https://pubmed.ncbi.nlm.nih.gov/28207669/Kevin R O'Neill, Jason G Smith, Amir M Abtahi...
https://pubmed.ncbi.nlm.nih.gov/21600853/Nathan Evaniew, Moin Khan, Brian Drew...
https://pubmed.ncbi.nlm.nih.gov/24838506/Windsor-Essex Compassionate Care Community
Lead Sponsor
Cairo University
Collaborating Sponsor