Clinical trial NCT03938467: Irrisept C.Acnes Study
Official title: Effect of Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate (Irrisept) on Incidence of Cutibacterium Acnes in Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty
Keywords: Shoulder Arthroplasty
C.acnes
Cutibacterium acnes
Irrisept
Lead sponsor: Orthopaedic Associates of Michigan, PC
Sponsor class: OTHER
Collaborators: name: Mercy Health
First posted: 2019-05-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Controlled Trial
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: C.acnes Growth Rate
timeFrame: 12 months
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 6 months
measure: ROM
timeFrame: 6 Months
measure: American Shoulder and Elbow Surgeons Shoulder Score (ASES)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan, PC
state: Michigan
Study officials:
References:
citation: 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.
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.
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.
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.
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.
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.
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.