NCT02968693

Drug Delivery Devices for Osteomyelitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Yulin Orthopedics Hospital of Chinese and Western Medicine · Academic / Other
• Sex: All
• Age: 15 Years – 68 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteomyelitis

Interventions

Type	Name	Description
DEVICE	antibiotic-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.
DEVICE	antibiotic-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.
DRUG	Vancomycin	Vancomycin powder was added into the combination therapy group and PMMA groups

Timeline

• Start date: 2011-04-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-11-18
• Last updated: 2018-11-27

Locations

2 sites across 1 country: China