Drug Delivery Devices for Osteomyelitis

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.

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Key information

Conditions

Osteomyelitis Bone Diseases Bone Diseases, Infectious Infections Musculoskeletal Diseases

Age range

15 year–68 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

antibiotic-loaded calcium sulfate

Device

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.

antibiotic-loaded polymethyl methacrylate

Device

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.

Vancomycin

Drug

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

Primary outcomes

complications after first-stage surgery.

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

Time frame: through study completion, an average of 24 months.

Sponsors and collaborators

Lead sponsor

Yulin Orthopedics Hospital of Chinese and Western Medicine

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Nov 18, 2016
Registry last updated: Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed