The Effect of Intrawound Vancomycin Powder in Spine Surgery

NCT ID: NCT04825522

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1643 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-27
• Study Completion Date: 2028-12-01

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.

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.

Conditions

Spine Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

Participants will not be receiving vancomycin.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

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

Interventions

Vancomycin

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

Intervention Type: DRUG

Other Intervention Names

Treatment group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Windsor-Essex Compassionate Care Community

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Soliman

Assistant Professor of Neurosurgery, General Neurosurgery Clinical Fellow, Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Soliman, MD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

Windsor Regional Hospital - Ouellette

Windsor, Ontario, Canada

Site Status: RECRUITING

Cairo University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Canada; Egypt

Central Contacts

Mohamed Soliman, MSc, MD

Role: CONTACT

msolim8@uwo.ca

17329241637

Abdalla Shamisa, FRCSC

Role: CONTACT

ashamisa@yahoo.ca

Facility Contacts

Abdalla Shamisa, MD

Role: primary

ashamisa@yahoo.ca

Balraj Jhawar, MD

Role: backup

bsjahwar@gmail.com

Noha Assem, MD

Role: primary

kasralainirec@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 29178308 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25608241 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24838506 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28207669 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21600853 (View on PubMed)

Other Identifiers

REB# 21-393

Identifier Type: -

Identifier Source: org_study_id