Project for application of Vancomycin on spinal arthrodesis with use of screws and rods

Not Applicable

• Conditions: Arthrodesis.; Z98.1; Clinal trial conducted on normal population with traumatic injury or degenerative disease of spinal column with indication of arthrodesis. Intention is to observe if there is less surgical site infection rates with use of topical vancomycin. Vancomycin; Clinical Trial

• Registration Number: RBR-57wppt
• Lead Sponsor: Hospital Cristo Redentor - Grupo Hospitalar Conceição

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Spinal column fracture with indication of fixation or degenerative disease with indication of spinal arthrodesis

Exclusion Criteria

Previous spinal arthrodesis; Known neoplasia; Denial on participation

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical site infection;Identification on clinical features like fever, purulent material drainage from surgical site. Specifics criteria from ANVISA, march 2009

Secondary Outcome Measures

Name	Time	Method
Chronic pain, pseudoartrosis.;Pain will be assessed by analogue visual scale of pain. Range from 0-10 where zero represents no pain and 10 represents maximum of pain.<br>Pseudoartrosis will be assessed by presence of pain on surgical site and specific imaging (x-ray) criteria of loosening of screws or no fusion.