The Effect of Intrawound Vancomycin Powder in Spine Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spine Disease
• Intervention / Treatment: Drug: Vancomycin

Detailed Description

Potential participants will be identified at the clinic, emergency department, or on the floor by history, clinical examination, and positive imaging findings. The surgeon will notify the study coordinator of the potential patient. The study coordinator will introduce the trial to the patient and obtain informed consent at the office during the clinic visit or his hospital stay. Patient's pre-operative data such as demographics (age and sex), presence of comorbidities like diabetes, ischemic heart disease, asthma patients on steroids, nutrition status using serum albumin level, and previous posterior spine surgical procedures at the operative level will be collected once the patient admitted prior to the procedure. The study coordinator will enroll the patient into the trial, and provide the appropriate intervention (vancomycin application, or no application) using the closed envelope technique of randomization to the neurosurgeon performing the procedure. Patients will also be blinded to avoid the placebo effect. All patients will receive the standard systemic antibiotic prophylaxis. The duration of the procedure, estimated blood loss, type of the procedure (instrumented versus non-instrumented) and the number of levels will be recorded. After the intervention, wound infections will be monitored during a follow-up period of 12 weeks from the date of surgery. Cultured organisms and subsequent treatments will be recorded. The primary outcome is the incidence of infection (either in-patient or in the follow-up). The secondary outcome is the development of other complications including Vancomycin related.

• Study Type: Interventional
• Enrollment (Estimated): 1643
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mohamed Soliman, MSc, MD; Phone Number: 17329241637; Email: msolim8@uwo.ca
• Study Contact Backup: Name: Abdalla Shamisa, FRCSC; Email: ashamisa@yahoo.ca

Study Locations

• Canada
  • Ontario
    • Windsor, Ontario, Canada, N9A 1E1
      • Recruiting
      • Windsor Regional Hospital - Ouellette
      • Contact: Abdalla Shamisa, MD; Email: ashamisa@yahoo.ca
      • Contact: Balraj Jhawar, MD; Email: bsjahwar@gmail.com
• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • Cairo University Hospitals
    • Contact: Noha Assem, MD; Email: kasralainirec@gmail.com
    • Principal Investigator: Helmy El-Dessouky, MD
    • Principal Investigator: Wael El Mahdy, MD, FRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients requiring surgery due to any spine disease.

Exclusion Criteria:

• A previous history of infections at the spine surgical site.
• Biopsy procedure.
• Patients with a postoperative follow-up time of less than 12 weeks.
• Patients allergic to vancomycin.
• Patient is less than 18 years old.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will not be receiving vancomycin.
Active Comparator: Vancomycin; For surgeries involving one level, 500mg of vancomycin will be applied. For surgeries involving greater than 1 level and less than 3 levels, 1gm will be applied and for surgeries greater than 3 levels, 2gms will be applied.	Drug: Vancomycin; During spinal surgery, participants will receive intrawound vancomycin powder in their wound before closure.; Other Names: Treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Infection	Number of patients with post-operative wound infection after spinal surgery (including the type of organism and duration of the procedure). 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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Number of patients who developed any complications related to the vancomycin.	3 months

Collaborators and Investigators

• Sponsor: Windsor-Essex Compassionate Care Community
• Collaborators: Cairo University
• Investigators: Principal Investigator: Mohamed Soliman, MD, Western University

Publications and helpful links

General Publications

• Xie LL, Zhu J, Yang MS, Yang CY, Luo SH, Xie Y, Pu D. Effect of Intra-wound Vancomycin for Spinal Surgery: A Systematic Review and Meta-analysis. Orthop Surg. 2017 Nov;9(4):350-358. doi: 10.1111/os.12356.
• Tomov M, Mitsunaga L, Durbin-Johnson B, Nallur D, Roberto R. Reducing surgical site infection in spinal surgery with betadine irrigation and intrawound vancomycin powder. Spine (Phila Pa 1976). 2015 Apr 1;40(7):491-9. doi: 10.1097/BRS.0000000000000789.
• Evaniew N, Khan M, Drew B, Peterson D, Bhandari M, Ghert M. Intrawound vancomycin to prevent infections after spine surgery: a systematic review and meta-analysis. Eur Spine J. 2015 Mar;24(3):533-42. doi: 10.1007/s00586-014-3357-0. Epub 2014 May 18.
• Hey HWD, Thiam DW, Koh ZSD, Thambiah JS, Kumar N, Lau LL, Liu KG, Wong HK. Is Intraoperative Local Vancomycin Powder the Answer to Surgical Site Infections in Spine Surgery? Spine (Phila Pa 1976). 2017 Feb 15;42(4):267-274. doi: 10.1097/BRS.0000000000001710.
• O'Neill KR, Smith JG, Abtahi AM, Archer KR, Spengler DM, McGirt MJ, Devin CJ. Reduced surgical site infections in patients undergoing posterior spinal stabilization of traumatic injuries using vancomycin powder. Spine J. 2011 Jul;11(7):641-6. doi: 10.1016/j.spinee.2011.04.025. Epub 2011 May 19.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: REB# 21-393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes