Drug Delivery Devices for Osteomyelitis

November 25, 2018 updated by: Shanchao Luo, Yulin Orthopedics Hospital of Chinese and Western Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
      • Yulin, Guangxi, China
        • Yulin Orthopedics Hospital of Chinese and Western Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 68 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Between April 2011 and April 2015, fifty-one patients requiring surgical treatment for chronic post-traumatic/postoperative osteomyelitis of the lower extremities were enrolled in a retrospective and control study in our hospital.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
combination therapy group
antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin
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
PMMA group
antibiotic-loaded polymethyl methacrylate and Vancomycin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complications after first-stage surgery.
Time Frame: through study completion, an average of 24 months.
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.
through study completion, an average of 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yulin Orthopedics Hospital of Chinese and Western Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 25, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150801c

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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