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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

Irrisept C.Acnes Study

Clinicaltrials.gov identifier NCT03938467

Recruitment Status Not yet recruiting

First Posted May 6, 2019

Last update posted August 28, 2019

Study Description

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:Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty
  • Intervention/Treatment: Drug: Antiseptic Cleanser
  • Phase: 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.

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: October 2021
  • Estimated Study Completion Date: October 2021
Arms and interventions
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.
Outcome Measures
  • 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.
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

United States, Michigan
Orthopaedic Associates of Michigan, PC
Grand Rapids

Sponsors and Collaborators

Orthopaedic Associates of Michigan, PC

Irrimax Corporation

Mercy Health

More Information