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

Project for application of Vancomycin on surgical site of thoracolumbar spinal arthrodesis with fusion material

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-57wppt
Enrollment
Unknown
Registered
2018-09-25
Start date
2014-07-23
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

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

Interventions

It will be applied standard technique to approach and fixation to perform spinal column arthrodesis in both groups. Subperiosteal dissection, musculoskeletal exposition to decompression and fusion w
Drug

Sponsors

Hospital Cristo Redentor - Grupo Hospitalar Conceição
Lead Sponsor
Hospital Cristo Redentor - Grupo Hospitalar Conceição
Collaborator

Eligibility

Age
16 Years to No maximum

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Previous spinal arthrodesis; Known neoplasia; Denial on participation

Design outcomes

Primary

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

Secondary

MeasureTime frame
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. Pseudoartrosis will be assessed by presence of pain on surgical site and specific imaging (x-ray) criteria of loosening of screws or no fusion.

Countries

Brazil

Contacts

Public ContactTobias Nascimento

Hospital Cristo Redentor - Grupo Hospitalar Conceição

tobiludw@gmail.com+555133574100

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 20, 2026