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Drug Delivery Devices for Osteomyelitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02968693
Enrollment
51
Registered
2016-11-18
Start date
2011-04-30
Completion date
2016-07-31
Last updated
2018-11-27

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

Conditions

Osteomyelitis

Brief summary

Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of the lower extremities were included in the retrospective investigation. The patients were assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA. Hematological parameters, eradication of infection, rate of infection recurrence and reoperation rate were evaluated during the follow-up.

Interventions

DEVICEantibiotic-loaded calcium sulfate

To obtain a paste suitable for pellets, the following steps should be used: 1. Empty 10 cc Stimulan® calcium sulfate powder (Stimulan; Biocomposites Ltd; United Kingdom) into a sterile mixing bowl. 2. The calcium sulfate powder was mixed with 2,000 mg of vancomycin powder. 3. Add approximately 5 ml mixing solution into the above mixture. Mix thoroughly until a smooth paste is formed (approximately 30 seconds). 4. The resultant paste is uniformly smooth into the mould provided to form pellets with diameters of 4.8 mm and height of 3.3 mm. 5. Allow paste to cure undisturbed for at least 15 minutes after mixing. Flex mould to release pellets.

DEVICEantibiotic-loaded polymethyl methacrylate

One sachet of 40g PALACOSR®+G power containing 33.6g PMMA and with the addition of 0.5g gentamicin sulphate (Heraeus Medical Gesellschaft mit beschränkter Haftung,Germany) was mixed with 4,000 mg of vancomycin powder in a sterile bowl. The liquid provided was poured into the resultant mixture above. Then, the mixture was stirred carefully for 30 sec. If the dough-like mass no longer sticked to the rubber gloves, it can be progressed. If the required consistency was obtained, the cement can be applied to the bony defect until it hardened completely.

DRUGVancomycin

Vancomycin powder was added into the combination therapy group and PMMA groups

Sponsors

Yulin Orthopedics Hospital of Chinese and Western Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 68 Years
Healthy volunteers
No

Inclusion criteria

* The retrospective study included patients with chronic post-traumatic or postoperative osteomyelitis and excluded patients suffering from hematogenous osteomyelitis or acute post-traumatic or postoperative osteomyelitis.

Exclusion criteria

* Other kinds of osteomyelitis.

Design outcomes

Primary

MeasureTime frame
complications after first-stage surgery.through study completion, an average of 24 months.
local infection recurrence after first-stage surgery.through study completion, an average of 24 months.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026