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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02385968
Date of registration: 04/03/2015
Prospective Registration: No
Primary sponsor: Sygehus Lillebaelt
Public title: Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR
Scientific title: Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR
Date of first enrolment: October 2014
Target sample size: 5
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02385968
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Name:     Karen H. Hansen
Address: 
Telephone:
Email:
Affiliation:  Sygehus Lillebaelt
Key inclusion & exclusion criteria

Inclusion Criteria:

- MRI-confirmed lumbar disc herniation.

- Age between 18 and 65 years.

- No prior spine surgery.

- No diagnosed dementia.

Exclusion Criteria:

- Antibiotic treatment within the previous two weeks.

- History of alcohol abuse, illicit drug use or drug abuse, or significant mental
illness

- Known immune deficiency state (e.g., positive for human immunodeficiency virus) or in
treatment with immunosuppressive drugs including high dose steroids or cyclosporine.

- Concurrent infections (infections of skin, urinary tract infection, other skin
diseases, e.g. Acne vulgaris).

- Previous epidural instrumentation.

- Uncontrolled, unstable or recently diagnosed autoimmune disease, including but not
limited to systemic lupus erythematosus, inflammatory bowel disease, sarcoidosis,
rheumatoid arthritis, or psoriasis.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Lumbar Disc Herniations
Intervention(s)
Primary Outcome(s)
Bacterial growth on a per-patient basis [Time Frame: at time of surgery]
Secondary Outcome(s)
Secondary ID(s)
S-20140085
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Vejle Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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