Decreasing Infection In Arthroscopic Shoulder Surgery
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|ClinicalTrials.gov Identifier: NCT02219776|
Recruitment Status : Unknown
Verified September 2016 by McLaren Health Care.
Recruitment status was: Recruiting
First Posted : August 19, 2014
Last Update Posted : September 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Post Operative Infection Arthroscopic Shoulder Surgery Infection||Drug: Benzoyl Peroxide solution Plus Chlorhexidine Scrub Other: Standard of Care - Chlorhexidine Scrub only||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Decreasing Proprionbacterium Acne Skin Colonization Prior to Arthroscopic Shoulder Surgery|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
Active Comparator: Chlorhexidine Standard of Care Arm
Use of Chlorhexidine to cleanse pre-operative surgery site
Other: Standard of Care - Chlorhexidine Scrub only
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
Drug: Benzoyl Peroxide solution Plus Chlorhexidine Scrub
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219776
|Contact: Landon R Fine, DOemail@example.com|
|United States, Michigan|
|McLaren Greater Lansing||Recruiting|
|Lansing, Michigan, United States, 28910|
|Contact: Patrick Noud, MD|
|Principal Investigator:||Landon R Fine, DO||McLaren Greater Lansing|