Recruiting

Vancomycin

Sponsor:

Windsor-Essex Compassionate Care Community

Code:

NCT04825522

Conditions

Spine Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vancomycin

Study Details

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

Study ID

NCT04825522

Start date

Mar 27, 2022

Status verified date

Apr, 2024

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1643 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Vancomycin

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

Primary outcome measure

  • Rate of Infection [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Mohamed Soliman, MSc, MD

17329241637msolim8@uwo.ca

Abdalla Shamisa, FRCSC

ashamisa@yahoo.ca

Locations

Windsor Regional Hospital - Ouellette

Recruiting

Windsor, Ontario, Canada, N9A 1E1

Contacts

Abdalla Shamisa, MD

ashamisa@yahoo.ca

Balraj Jhawar, MD

bsjahwar@gmail.com

More Information

Sponsor

Windsor-Essex Compassionate Care Community

Last update posted

Apr 23, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Windsor-Essex Compassionate Care Community on 2024-04-23.