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Decreasing Infection In Arthroscopic Shoulder Surgery

Primary Purpose

Post Operative Infection Arthroscopic Shoulder Surgery, Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Benzoyl Peroxide solution Plus Chlorhexidine Scrub
Standard of Care - Chlorhexidine Scrub only
Sponsored by
McLaren Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Infection Arthroscopic Shoulder Surgery focused on measuring Infection,, Proprionbacterium Acne,, Shoulder,, skin preparation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • McLaren Greater Lansing

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chlorhexidine Standard of Care Arm

Benzoyl Peroxide Experimental Arm

Arm Description

Use of Chlorhexidine to cleanse pre-operative surgery site

Use of Chlorhexidine scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient

Outcomes

Primary Outcome Measures

Bacterial Growth
Skin swabs and biopsy will be cultured for 14 days in media specific for growing P.Acne

Secondary Outcome Measures

Full Information

First Posted
August 16, 2014
Last Updated
August 23, 2022
Sponsor
McLaren Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT02219776
Brief Title
Decreasing Infection In Arthroscopic Shoulder Surgery
Official Title
Decreasing Proprionbacterium Acne Skin Colonization Prior to Arthroscopic Shoulder Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McLaren Health Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Infection Arthroscopic Shoulder Surgery, Infection
Keywords
Infection,, Proprionbacterium Acne,, Shoulder,, skin preparation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine Standard of Care Arm
Arm Type
Active Comparator
Arm Description
Use of Chlorhexidine to cleanse pre-operative surgery site
Arm Title
Benzoyl Peroxide Experimental Arm
Arm Type
Experimental
Arm Description
Use of Chlorhexidine scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient
Intervention Type
Drug
Intervention Name(s)
Benzoyl Peroxide solution Plus Chlorhexidine Scrub
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard of Care - Chlorhexidine Scrub only
Intervention Description
Subjects will be given instructions on how to apply the Chlorhexidine using a scrub brush
Primary Outcome Measure Information:
Title
Bacterial Growth
Description
Skin swabs and biopsy will be cultured for 14 days in media specific for growing P.Acne
Time Frame
14 days from culture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Landon R Fine, DO
Organizational Affiliation
McLaren Greater Lansing
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLaren Greater Lansing
City
Lansing
State/Province
Michigan
ZIP/Postal Code
28910
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Decreasing Infection In Arthroscopic Shoulder Surgery

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