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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, Randomized, Controlled Trial|
|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|
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.
- C.acnes Growth Rate [ Time Frame: 12 months ]To compare the rate of C.acnes using two different antiseptic protocols
- 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)]
- ROM [ Time Frame: 6 Months ]Range of Motion
- 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.
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
|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 firstname.lastname@example.org|
|Contact: Melissa Chavez, BS 616-459-7101 ext 6140 email@example.com|
|Principal Investigator: Tim R Lenters, MD|