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Irrisept C.Acnes Study

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ClinicalTrials.gov Identifier: NCT03938467
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : August 27, 2019
Sponsor:
Collaborators:
Irrimax Corporation
Mercy Health
Information provided by (Responsible Party):
Tim Lenters, Orthopaedic Associates of Michigan, PC

Brief Summary:
A Prospective, Randomized, Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes

Condition or disease Intervention/treatment Phase
Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty Drug: Antiseptic Cleanser Phase 4

Detailed Description:
The purpose of this prospective randomized control trial is to access outcomes of positive culture growth of C. acnes from specimens obtained from the shoulders of patients undergoing primary shoulder arthroplasty whose intraoperative management includes Irrisept antiseptic irrigation and compare it to patients whose management includes standard of care prophylaxis wipes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized, Controlled Trial
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate (Irrisept) on Incidence of Cutibacterium Acnes in Shoulder Arthroplasty
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Antiseptic Cleanser
Standard prophylaxis will be administered by Irrisept patients as would individuals in the control group. In addition, these Irrisept study subjects will be supplemented with the use of Irrisept irrigation by the study surgeon during the patient's surgical procedure. Standard times for irrigation will include immediately after incision through the dermal layer, and immediately prior to implantation of any prosthetic components. Final irrigation will be performed just prior to closure of the deltopectoral interval.
Drug: Antiseptic Cleanser
Contains 0.05% Chlorhexidine gluconate in sterile water for irrigation. The mechanical action of the Irrisept system removes bacteria and debris without harming underlying tissues. Irrisept has demonstrated broad spectrum bactericidal activity against antibiotic-resistant strains. Its contents are wrapped in two sequential sterilization wraps which repel water blood, and saline, making it effective against both air and water borne bacteria.
Other Name: Irrisept Wound Cleansing System

No Intervention: Standard of Care Prophylaxis
Standard prophylaxis includes use of chlorhexidine wipes (Sage cloth) the night before and morning of surgery on the surgical site over the anterior shoulder.



Primary Outcome Measures :
  1. C.acnes Growth Rate [ Time Frame: 12 months ]
    To compare the rate of C.acnes using two different antiseptic protocols


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 6 months ]
    Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: [0 (no pain) - 10 (worse possible pain)]

  2. ROM [ Time Frame: 6 Months ]
    Range of Motion

  3. American Shoulder and Elbow Surgeons Shoulder Score (ASES) [ Time Frame: 6 Months ]
    the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures.



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

Inclusion Criteria:

  1. Patient has signed the IRB-approved informed consent form specific to this study prior to undergoing any research related procedures
  2. Patient can read and understand English
  3. Patient who will undergo a primary shoulder arthroplasty
  4. Patient is over the age of 18

Exclusion Criteria:

  1. Patient who has had a previous surgery on the ipsilateral shoulder
  2. Patient has a known allergy to topical iodine or Chlorohexidine gluconate.
  3. Patient has had non-surgical prophylaxis antibiotic treatment within 14 days of index surgery
  4. Patient requires a revision procedure for a previous ipsilateral shoulder surgery
  5. Patient has any significant pathology that, in the opinion of investigator, makes the patient unsuitable for study participation
  6. Patient is a pregnant woman

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 ClinicalTrials.gov identifier (NCT number): NCT03938467


Locations
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United States, Michigan
Orthopaedic Associates of Michigan, PC Not yet recruiting
Grand Rapids, Michigan, United States, 49525
Contact: Michelle A Padley, MS    616-459-7101 ext 1797    michelle.padley@oamichigan.com   
Contact: Melissa Chavez, BS    616-459-7101 ext 6140    mchavez@rvorthopedics.com   
Principal Investigator: Tim R Lenters, MD         
Sponsors and Collaborators
Orthopaedic Associates of Michigan, PC
Irrimax Corporation
Mercy Health

Publications:

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Responsible Party: Tim Lenters, Orthopedic Surgeon, Orthopaedic Associates of Michigan, PC
ClinicalTrials.gov Identifier: NCT03938467     History of Changes
Other Study ID Numbers: RVO-IRR-2019
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tim Lenters, Orthopaedic Associates of Michigan, PC:
Shoulder Arthroplasty
C.acnes
Cutibacterium acnes
Irrisept
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents