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A prospective multicenter clinical study of debridement-reconstruction-docking (DRD) three-step therapy based on precise diagnosis in the treatment of limb bone infection

A prospective multicenter clinical study of debridement-reconstruction-docking (DRD) three-step therapy based on precise diagnosis in the treatment of limb bone infection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085944
Enrollment
Unknown
Registered
2024-06-21
Start date
2024-06-25
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

osteomyelitis

Interventions

control:Traditional osteomyelitis surgical procedure
DRD group:Osteomyelitis diagnosis and treatment algorithm using DRD

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with limb bone infection through clinical manifestations, laboratory examinations, imaging examinations, pathogenic microbiology examinations or pathological biopsies in the research unit. Clinical manifestations include redness, swelling, heat and pain of the affected limb, sinus tract formation, pus and exudate, excretion of dead bones, and internal fixation and exposure. Imaging examination showed local bone destruction, bone marrow edema, PET/CT local hyperintensity, etc. or biopsy results of deep infected tissue, positive bacterial culture or microbial metagene sequencing; or special staining of histopathology confirms the presence of pathogenic microorganisms in the suspected infected tissue during surgery; or 5 neutrophils in each high-magnification (×400x) field of view, 5 neutrophils in each high-magnification field = used as a pathological diagnostic criterion for bone infection. (2) The patient has the desire to treat the limb bone infection through surgery. (3) Patients who meet the indications for surgical treatment.

Exclusion criteria

Exclusion criteria: (1) Patients with infected bone lesions of the limbs involving adjacent joints. (2) Patients who are allergic to metal or cannot withstand long-term external fixation stents. (3) Patients with poor cardiopulmonary function, liver and kidney function, unable to tolerate surgical treatment or have contraindications to surgery. (4) Patients with clear contraindications to anesthesia.

Design outcomes

Primary

MeasureTime frame
Recurrence rate of osteomyelitis infection of the extremities;

Secondary

MeasureTime frame
Externally fixed index;Refracture rate;Paley Bone Healing Score;

Countries

China

Contacts

Public ContactHan Pei

Shanghai Sixth People‘s Hospital

hanpei_cn@163.com+86 189 3017 3620

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026