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A prospective randomized controlled clinical study on the antibiotic application scheme after debridement of chronic osteomyelitis

A prospective randomized controlled clinical study on the antibiotic application scheme after debridement of chronic osteomyelitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091836
Enrollment
Unknown
Registered
2024-11-05
Start date
2024-11-17
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

osteomyelitis

Interventions

Experimental Group:The duration of postoperative antibiotic therapy was shortened from 6 weeks to 3 weeks
Experimental Group:Postoperative antibiotics were adjusted from 2 weeks of intravenous administration + 4 weeks of oral administration to 1 week of intravenous administration + 2 weeks of oral adminis

Sponsors

The People’s Liberation Army Joint Logistic Support Force Hospital 920
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 18-70 years old, regardless of gender; 2. Clearly diagnosed with chronic osteomyelitis of long bones of the limbs, Cinery-Mader anatomical classification of type I, III or IV, and physiological classification of grade A or B. Chronic osteomyelitis of the limb bones includes one of the following: a. Local pain, b. Local redness and swelling, c. Body temperature > 38.0ºC, d. Accompanied by drainage sinus tract, clinical evaluation requires appropriate surgical intervention for necrotic tissue; 3. Has not received local/systemic anti-infective drug treatment within 1 month, and can accept/tolerate gastrointestinal administration; 4. Agree and voluntarily sign the informed consent form; 5. Life expectancy > 1 year.

Exclusion criteria

Exclusion criteria: 1. Patients with chronic osteomyelitis of Cinery-Mader anatomical type II and physiological grade C; or patients with chronic osteomyelitis in the stable period who do not need surgical debridement; 2. Patients who have been treated with antibiotics for a long time due to infection within one month before the visit; 3. Patients with tuberculosis, fungi, parasites or viruses who need treatment; 4. Patients with peripheral arterial disease; 5. Patients with poor blood sugar control in diabetes; 6. Patients who are mentally or physically unable to tolerate oral medication; 7. Patients with malignant tumors or chronic diseases who need to continue to receive drug treatment (such as anti-tumor radiotherapy and chemotherapy, use of glucocorticoids or immunosuppressants, use of dual antibodies for coronary heart disease, chronic liver disease, chronic renal insufficiency, etc.). 8. Patients who are considered unsuitable by researchers due to poor treatment compliance. 9. Patients diagnosed with suppurative arthritis or periprosthetic infection.

Design outcomes

Primary

MeasureTime frame
C-reactive protein;Erythrocyte sedimentation rate;X-ray examination is normal;Clinical symptoms disappeared;No dead bone formation;

Secondary

MeasureTime frame
Bacterial strain detection rate;

Countries

China

Contacts

Public ContactShi Jian

The People’s Liberation Army Joint Logistic Support Force Hospital 920

doctorshijian920@sina.com+86 138 8846 1536

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026