Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder ArthroplastyPhase 4NCT03938467

Irrisept C.Acnes Study

A Phase 4 study testing Antiseptic Cleanser in people with Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty, run by Orthopaedic Associates of Michigan, PC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty
What is being tested?: Antiseptic Cleanser
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2021to 1 Jan 2024
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, 49525

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty
Being tested: Antiseptic Cleanser
Keywords: Shoulder Arthroplasty, C.acnes, Cutibacterium acnes, Irrisept

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Antiseptic CleanserDrug
Also called Irrisept Wound Cleansing System
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.

Study groups in NCT03938467
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

C.acnes Growth Rate
To compare the rate of C.acnes using two different antiseptic protocols
Measured: 12 months

Secondary outcomes (3)

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)]
Measured: 6 months
ROM
Range of Motion
Measured: 6 Months
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures.
Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20211 Jan 2024

First posted6 May 2019
Study start1 Mar 2021
Primary completion1 Jul 2023
Study completion1 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder ArthroplastyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, Randomized, Controlled Trial
Masking: Single blind
Who is masked: Participant
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03938467
Sponsor's protocol ID: RVO-IRR-2019
Status last verified: Jun 2024
First submitted: 2 May 2019
Last updated: 21 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 25979553
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.
PubMed 22981447
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.
PubMed 24306704
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.
PubMed 25547858
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.
PubMed 26085528
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.
PubMed 25483906
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.
PubMed 26067191

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate (Irrisept) on Incidence of Cutibacterium Acnes in Shoulder Arthroplasty
ClinicalTrials.gov ID: NCT03938467
Acronym / sponsor ID: RVO-IRR-2019
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
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Orthopaedic Associates of Michigan, PCUniversity, hospital or other
Collaborators: Mercy Health
Study start: 1 Mar 2021 (actual)
Primary completion: 1 Jul 2023 (actual)
Study completion: 1 Jan 2024 (actual)
First posted: 6 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Prospective, Randomized, Controlled Trial

Arm	Type	Receives
Antiseptic Cleanser	Experimental	Drug: Antiseptic CleanserStandard 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 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Antiseptic CleanserAlso: Irrisept Wound Cleansing SystemContains 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.	Drug	Antiseptic Cleanser

Primary outcome

C.acnes Growth Rate
Time frame: 12 months
To compare the rate of C.acnes using two different antiseptic protocols

3 secondary outcomes

Visual Analog Scale (VAS)
Time frame: 6 months
ROM
Time frame: 6 Months
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time frame: 6 Months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Background: PubMed 25979553Horneff 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.
Background: PubMed 22981447Levy 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.
Background: PubMed 24306704Matsen 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.
Background: PubMed 25547858Matsen 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.
Background: PubMed 26085528Mook 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.
Background: PubMed 25483906Sethi 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.
Background: PubMed 26067191Sabetta 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C.acnes Growth Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03938467, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.