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Irrisept C.Acnes Study

Primary Purpose

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

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Antiseptic Cleanser

About this trial

This is an interventional prevention trial for Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty focused on measuring Shoulder Arthroplasty, C.acnes, Cutibacterium acnes, Irrisept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Orthopaedic Associates of Michigan, PCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Antiseptic Cleanser

Standard of Care Prophylaxis

Arm Description

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.

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

Outcomes

Primary Outcome Measures

C.acnes Growth Rate

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

Secondary Outcome Measures

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)]

ROM

Range of Motion

American Shoulder and Elbow Surgeons Shoulder Score (ASES)

the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures.

Full Information

NCT ID

NCT03938467

First Posted

May 2, 2019

Last Updated

May 20, 2021

Sponsor

Orthopaedic Associates of Michigan, PC

Collaborators

Mercy Health

1. Study Identification

Unique Protocol Identification Number

NCT03938467

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Orthopaedic Associates of Michigan, PC

Collaborators

Mercy Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Prospective, Randomized, Controlled Trial

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Antiseptic Cleanser

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care Prophylaxis

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Antiseptic Cleanser

Other Intervention Name(s)

Irrisept Wound Cleansing System

Intervention Description

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.

Primary Outcome Measure Information:

Title

C.acnes Growth Rate

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Visual Analog Scale (VAS)

Description

Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: [0 (no pain) - 10 (worse possible pain)]

Time Frame

6 months

Title

ROM

Description

Range of Motion

Time Frame

6 Months

Title

American Shoulder and Elbow Surgeons Shoulder Score (ASES)

Description

the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures.

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Orthopaedic Associates of Michigan, PC

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49525

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michelle A Padley, MS

Phone

616-459-7101

Ext

1797

michelle.padley@oamichigan.com

First Name & Middle Initial & Last Name & Degree

Daisy Gomez De Leon, BS

Phone

616-459-7101

Ext

2021

Daisy.GomezDeLeon@oamichigan.com

First Name & Middle Initial & Last Name & Degree

Tim R Lenters, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25979553

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.

Results Reference

background

PubMed Identifier

22981447

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.

Results Reference

background

PubMed Identifier

24306704

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.

Results Reference

background

PubMed Identifier

25547858

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.

Results Reference

background

PubMed Identifier

26085528

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.

Results Reference

background

PubMed Identifier

25483906

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.

Results Reference

background

PubMed Identifier

26067191

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.

Results Reference

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Irrisept C.Acnes Study

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