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NCT03938467 Clinical Trial

Irrisept C.Acnes Study

Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty Clinical Trial

Official title:
Effect of Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate (Irrisept) on Incidence of Cutibacterium Acnes in Shoulder Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03938467
Other study ID # RVO-IRR-2019
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2021
Est. completion date October 1, 2023

Study information
Verified date May 2021
Source Orthopaedic Associates of Michigan, PC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Acne Vulgaris
  • Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty

Intervention

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.

Locations
Country Name City State
United States Orthopaedic Associates of Michigan, PC Grand Rapids Michigan

Sponsors (2)
Lead Sponsor Collaborator
Orthopaedic Associates of Michigan, PC Mercy Health

Country where clinical trial is conducted

United States, 

References & Publications (7)

Horneff JG 3rd, Hsu JE, Voleti PB, O'Donnell J, Huffman GR. Propionibacterium acnes infection in shoulder arthroscopy patients with postoperative pain. J Shoulder Elbow Surg. 2015 Jun;24(6):838-43. doi: 10.1016/j.jse.2015.03.008. — View Citation

Levy O, Iyer S, Atoun E, Peter N, Hous N, Cash D, Musa F, Narvani AA. Propionibacterium acnes: an underestimated etiology in the pathogenesis of osteoarthritis? J Shoulder Elbow Surg. 2013 Apr;22(4):505-11. doi: 10.1016/j.jse.2012.07.007. Epub 2012 Sep 13. — View Citation

Matsen FA 3rd, Butler-Wu S, Carofino BC, Jette JL, Bertelsen A, Bumgarner R. Origin of propionibacterium in surgical wounds and evidence-based approach for culturing propionibacterium from surgical sites. J Bone Joint Surg Am. 2013 Dec 4;95(23):e1811-7. doi: 10.2106/JBJS.L.01733. — View Citation

Matsen FA 3rd, Russ SM, Bertelsen A, Butler-Wu S, Pottinger PS. Propionibacterium can be isolated from deep cultures obtained at primary arthroplasty despite intravenous antimicrobial prophylaxis. J Shoulder Elbow Surg. 2015 Jun;24(6):844-7. doi: 10.1016/j.jse.2014.10.016. Epub 2014 Dec 26. — View Citation

Mook WR, Klement MR, Green CL, Hazen KC, Garrigues GE. The Incidence of Propionibacterium acnes in Open Shoulder Surgery: A Controlled Diagnostic Study. J Bone Joint Surg Am. 2015 Jun 17;97(12):957-63. doi: 10.2106/JBJS.N.00784. — View Citation

Sabetta JR, Rana VP, Vadasdi KB, Greene RT, Cunningham JG, Miller SR, Sethi PM. Efficacy of topical benzoyl peroxide on the reduction of Propionibacterium acnes during shoulder surgery. J Shoulder Elbow Surg. 2015 Jul;24(7):995-1004. doi: 10.1016/j.jse.2015.04.003. — View Citation

Sethi PM, Sabetta JR, Stuek SJ, Horine SV, Vadasdi KB, Greene RT, Cunningham JG, Miller SR. Presence of Propionibacterium acnes in primary shoulder arthroscopy: results of aspiration and tissue cultures. J Shoulder Elbow Surg. 2015 May;24(5):796-803. doi: 10.1016/j.jse.2014.09.042. Epub 2014 Dec 4. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary C.acnes Growth Rate To compare the rate of C.acnes using two different antiseptic protocols 12 months
Secondary Visual Analog Scale (VAS) Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: [0 (no pain) - 10 (worse possible pain)] 6 months
Secondary ROM Range of Motion 6 Months
Secondary American Shoulder and Elbow Surgeons Shoulder Score (ASES) the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures. 6 Months