- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219776
Decreasing Infection In Arthroscopic Shoulder Surgery
Decreasing Proprionbacterium Acne Skin Colonization Prior to Arthroscopic Shoulder Surgery
Study Overview
Status
Detailed Description
With IRB approval and informed consent to participate in the study, patients scheduled for elective shoulder arthroscopy will be randomly selected and placed into 1 of 2 groups. Both groups will adhere to the surgeon's preoperative protocol of showering the night before with instructions to scrub the operative shoulder including the axilla with a chlorhexidine scrub brush. Group 1 will be treated "per protocol" and only be given instructions to use chlorhexidine. While group 2 will be provided a chlorhexidine scrub brush and a 1.5oz bottle of 10% benzoyl peroxide emollient to be applied after using the chlorhexidine scrub. The benzoyl peroxide should not be washed off prior to surgery.
Thirty minutes prior to incision, intravenous antibiotics, cefazolin or clindamycin if penicillin intolerant, will be administered per protocol. Dry anaerobic culturettes will be taken at the location of the expected posterior portal location before and after the application of the chloraprep solution. At the time of surgery both groups will undergo preoperative skin preparation, in sterile fashion, with our institutions "standard" protocol utilizing ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol; Enturia, El Paso, Texas). In addition, a 3mm full thickness skin punch biopsy will be taken after, application of chlorprep. Biopsies will be immediately placed, by the surgeon, in sterile receptacle with sterile saline and sent to our microbiology department. The biopsy site will be incorporated into the portal incision and will be closed appropriately minimizing the morbidity of obtaining the biopsy.
The culture results will be recorded into a "dummy" account on McLaren's electronic medical records program. This account ensures that the costs of the study are not charged to the patient as well as blinding the patient and surgeon of the their results. The patient correlating information will only be known to Dr. Fine and they will be kept in a password protect computer document which will be kept in a off campus protected locked location.
The Microbiology lab will place the swab specimens in 1 ml of saline, vortex them, and inoculate 0.01 mL onto an anaerobic blood agar plate. A chopped meat broth will also be inoculated. The punch biopsies will be ground and then inoculated to an anaerobic blood agar plate and a chopped meat broth. The anaerobic plates will be incubated in an anaerobic chamber at 35°C. The plates and broth will be examined daily for the first 4 days, then on days 7, 10 and 14 and any growth screened to determine if P. acnes is present. Results will be reported as "no P. acnes isolated" or as "<X>CFU/mL P. acnes" for the swab specimens. No colony count can be issued for the biopsies. These will be reported semi-quantitatively as rare, few, moderate or many. All plates will be read and counted manually by a laboratory technician who is not involved in the study and has been blinded from preoperative prep used. If any growth is detected, the sample will be considered positive.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Michigan
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Lansing, Michigan, United States, 28910
- Mclaren Greater Lansing
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Elective arthroscopic shoulder surgery
- Ages > 18
- Male and Female
Exclusion criteria:
- Active Infection
- History of ipsilateral prior shoulder surgery
- History of prior shoulder infection
- Current use of Antibiotics
- History of immunosuppression
- Open wounds
- History of Inflammatory arthritis
- Allergy to benzoyl peroxide
- Allergy to chlorhexidine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Chlorhexidine Standard of Care Arm
Use of Chlorhexidine to cleanse pre-operative surgery site
|
Subjects will be given instructions on how to apply the Chlorhexidine using a scrub brush
|
Experimental: Benzoyl Peroxide Experimental Arm
Use of Chlorhexidine scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient
|
Subjects will be provided instructions on how to use and apply the chlorhexidine using a scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bacterial Growth
Time Frame: 14 days from culture
|
Skin swabs and biopsy will be cultured for 14 days in media specific for growing P.Acne
|
14 days from culture
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Landon R Fine, DO, Mclaren Greater Lansing
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201400113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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