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The Effect of Intrawound Vancomycin Powder in Spine Surgery

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04825522
Enrollment
1643
Registered
2021-04-01
Start date
2022-03-27
Completion date
2028-12-01
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine Disease

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.

Interventions

DRUGVancomycin

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

Sponsors

Cairo University
CollaboratorOTHER
Windsor-Essex Compassionate Care Community
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

The patients will not know if they received vancomycin or not.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of Infection3 monthsNumber 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.

Secondary

MeasureTime frameDescription
Complications3 monthsNumber of patients who developed any complications related to the vancomycin.

Countries

Canada, Egypt

Contacts

Primary ContactMohamed Soliman, MSc, MD
msolim8@uwo.ca17329241637
Backup ContactAbdalla Shamisa, FRCSC
ashamisa@yahoo.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026