Irrisept C.Acnes Study

NCT03938467 | Completed Phase 4 FDA Drug

• 1 other identifier: RVO-IRR-2019
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• C.acnes Growth Rate

  To compare the rate of C.acnes using two different antiseptic protocols

  12 months

Secondary Outcomes (3)

• Visual Analog Scale (VAS)

  6 months

• ROM

  6 Months

• American Shoulder and Elbow Surgeons Shoulder Score (ASES)

  6 Months

Study Arms (2)

Antiseptic Cleanser

EXPERIMENTAL

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

Standard of Care Prophylaxis

NO INTERVENTION

Standard prophylaxis includes use of chlorhexidine wipes (Sage cloth) the night before and morning of surgery on the surgical site over the anterior shoulder.

Interventions

Antiseptic Cleanser DRUG

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.

Also known as: Irrisept Wound Cleansing System

Antiseptic Cleanser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Orthopaedic Associates of Michigan, PC: lead
• Mercy Health: collaborator

Study Sites (1)

Orthopaedic Associates of Michigan, PC

Grand Rapids, Michigan, 49525, United States

Location

Related 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.

  PMID: 25979553 BACKGROUND

• 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.

  PMID: 22981447 BACKGROUND

• 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.

  PMID: 24306704 BACKGROUND

• 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.

  PMID: 25547858 BACKGROUND

• 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.

  PMID: 26085528 BACKGROUND

• 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.

  PMID: 25483906 BACKGROUND

• 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.

  PMID: 26067191 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Model Details: Prospective, Randomized, Controlled Trial

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: March 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: January 1, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)