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Clinical and radiological comparison of patients undergoing treatment for bone infection using standard treatment and the use of a product that replaces bone and can hold antibiotics

Clinical and radiological comparison of patients undergoing surgical treatment of Osteomyelitis with conventional treatment and the use of synthetic graft with antibiotic

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6mwdg92
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-07-01
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

Other chronic Osteomyelitis

Interventions

This is a randomized controlled clinical study with two arms, double-blind prospective with patients osteomyelitis undergoing surgical procedures at the National Institute of Traumatology and Orthoped
E04.555.120

Sponsors

Ministerio da Saúde - Instituto Nacional de Traumatologia e Ortopedia/INTO
Lead Sponsor
Hospital Estadual de Traumatologia e Ortopedia Dona Lindu
Collaborator
Hospital universitário Pedro Ernesto
Collaborator
Hospital Estadual de Traumatologia e Ortopedia Vereador Mechiades Calazans
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients with osteomyelitis measuring up to 3 cm on radiograph; patients with soft tissue conditions for bone transport or compression-distraction surgery (traditional form of surgical treatment for osteomyelitis); presence of active fistula even with low secretion output

Exclusion criteria

Exclusion criteria: Presence of systemic signs of infection; lesions compatible with osteomyelitis in the metaphyseal region that make the installation of an external fixator unfeasible; tumor lesions; impossibility of standardized outpatient postoperative monitoring; pregnant patients

Design outcomes

Primary

MeasureTime frame
We hope that the use of synthetic graft with antibiotics will accelerate the consolidation process, bringing less morbidity to the treatment of osteomyelitis of long bones.—

Secondary

MeasureTime frame
Secondary outcomes are not expected—

Countries

Brazil

Contacts

Public ContactDiego Motta

Instituto Nacional de Traumatologia e Ortopedia - INTO/RJ

dieggomotta@gmail.com+55-21-21345000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)