Drug Delivery Devices for Osteomyelitis

Osteomyelitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02968693
• Other study ID #: 20150801c
• Status: Completed
• Start date: April 2011
• Est. completion date: July 2016

Study information

• Verified date: November 2018
• Source: Yulin Orthopedics Hospital of Chinese and Western Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteomyelitis

Intervention

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.
• 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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Yulin Orthopedics Hospital of Chinese and Western Medicine	Yulin	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Yulin Orthopedics Hospital of Chinese and Western Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications after first-stage surgery.		through study completion, an average of 24 months.
Primary	local infection recurrence after first-stage surgery.		through study completion, an average of 24 months.