The Effect of Intrawound Vancomycin Powder in Spine Surgery

NCT04825522 | Recruiting Phase 4 FDA Drug

• 1 other identifier: REB# 21-393
• Study Type: interventional
• Target: 1,643
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Spine Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complications

  3 months

Study Arms (2)

Control

NO INTERVENTION

Participants will not be receiving vancomycin.

Vancomycin

ACTIVE COMPARATOR

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

Interventions

Vancomycin DRUG

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

Also known as: Treatment group

Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring surgery due to any spine disease.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Windsor-Essex Compassionate Care Community: lead
• Cairo University: collaborator

Study Sites (2)

Windsor Regional Hospital - Ouellette

Windsor, Ontario, N9A 1E1, Canada

RECRUITING

Cairo University Hospitals

Cairo, 11562, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 29178308 BACKGROUND

• 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.

  PMID: 25608241 BACKGROUND

• 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.

  PMID: 24838506 BACKGROUND

• 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.

  PMID: 28207669 BACKGROUND

• 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.

  PMID: 21600853 BACKGROUND

MeSH Terms

Conditions

Spinal Diseases

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mohamed Soliman, MD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Soliman, MSc, MD

CONTACT

17329241637; msolim8@uwo.ca

Abdalla Shamisa, FRCSC

CONTACT

ashamisa@yahoo.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will not know if they received vancomycin or not.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery, General Neurosurgery Clinical Fellow, Principle Investigator

Model Details: Experimental Group: 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. Control Group: Will not receive any extra treatment.

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: March 27, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); EG (1)