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Decreasing Infection In Arthroscopic Shoulder Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02219776
Recruitment Status : Recruiting
First Posted : August 19, 2014
Last Update Posted : January 29, 2020
Information provided by (Responsible Party):
McLaren Health Care

Brief Summary:
Despite the use of a standard preoperative skin disinfectant prior to shoulder surgery propionibacterium acne remains a leading cause of post-operative infections. The purpose of this study is to evaluate effectiveness of topical benzoyl peroxide as an adjuvant to chlorhexidine-impregnated skin preparation in attempting to lower the colonization propionibacterium acne prior to surgery. This study will take cultures from patients who are randomly assigned into groups that receive and do not receive benzoyl peroxide as additional skin prep prior to elective shoulder surgery and compare quantified culture results.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Decreasing Proprionbacterium Acne Skin Colonization Prior to Arthroscopic Shoulder Surgery
Study Start Date : September 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  1. Elective arthroscopic shoulder surgery
  2. Ages > 18
  3. Male and Female

Exclusion criteria:

  1. Active Infection
  2. History of ipsilateral prior shoulder surgery
  3. History of prior shoulder infection
  4. Current use of Antibiotics
  5. History of immunosuppression
  6. Open wounds
  7. History of Inflammatory arthritis
  8. Allergy to benzoyl peroxide
  9. Allergy to chlorhexidine

Information from the National Library of Medicine

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 identifier (NCT number): NCT02219776

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Contact: Landon R Fine, DO 3038849611

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United States, Michigan
McLaren Greater Lansing Recruiting
Lansing, Michigan, United States, 28910
Contact: Patrick Noud, MD         
Sponsors and Collaborators
McLaren Health Care
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Principal Investigator: Landon R Fine, DO McLaren Greater Lansing
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Responsible Party: McLaren Health Care Identifier: NCT02219776    
Other Study ID Numbers: 201400113
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by McLaren Health Care:
Proprionbacterium Acne,
skin preparation
Additional relevant MeSH terms:
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Communicable Diseases
Chlorhexidine gluconate
Benzoyl Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents