Degenerative OsteoarthritisPhase 4NCT03849885
Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty
A Phase 4 study testing Benzoyl peroxide gel in people with Degenerative Osteoarthritis, run by Colorado Joint Replacement at 1 site in United States.
Trial summary
This study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called Propionibacterium, more specifically P acnes, the same bacterium that is responsible for the majority of acne. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Osteoarthritis
- What is being tested?
- Benzoyl peroxide gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2019to 31 Dec 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are 18 to 79 85 years of age
- CJR primary joint arthroplasty patients who are receiving care at Porter Adventist Hospital
- CJR established primary knee or hip arthroplasty patients with a native hip joint (no replacement on the biopsy side) who volunteers as a research participant.
- CJR patients without a previous arthroplasty procedure who have established care with our practice.
Who cannot join
- Previous history of hip infection
- Current antibiotic use or antibiotic use within the past week
- Previous history of Cutibacterium joint infection
- Current immunodeficiency disease or disorder
- Patients with active psoriatic disease or other focal inflammation over the hip
- Previous total hip arthroplasty (bilateral for the case of TKA patients and healthy volunteers, contralateral for THA patients)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Colorado Joint Replacement
Denver, Colorado, 80210
Roseann Johnson, 303-260-2940, RoseannJohnson@centura.org
Jason Jennings, MD
About this study
This study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called Propionibacterium, more specifically P acnes, the same bacterium that is responsible for the majority of acne. Information affecting hip surgery is currently unknown.
Read the detailed description
This study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called Propionibacterium. The most common bacterium of this family is P acnes, the same bacterium that is responsible for the majority of acne. There is increasing evidence that infection with P acnes and other Propionibacterium is a significant source of failure following certain orthopaedic shoulder procedures. However, information affecting hip surgery is currently unknown. Our personal experience leads us to believe that the numbers are actually quite high, since we are seeing an increased rate of Propionibacterium infection of hip replacement in the community. However, this type of study has never been done before, and therefore we simply do not know an accurate estimate for the average hip replacement patient's risk for Propionibacterium infection following hip replacement.
- Conditions
- Degenerative Osteoarthritis
- Being tested
- Benzoyl peroxide gel
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzoyl peroxide gelDrug
Also called Acne Medication
Skin prep with Chlorohexidine wipes and BPO.
| Study group | Role | What they receive |
|---|---|---|
| Standard Skin Prep | No intervention | Patients will undergo a skin cleansing protocols using 4% Chlorhexidine gluconate (CHG) cloths. After the skin prep, three 3-mm punch (Acu-Punch, Acuderm, Fort Lauderdale, FL) skin biopsies will performed for both an anterior-based hypothetical incision, and for a more lateral/posterior incision, for a total of 6 biopsies taken per subject. |
| Experimental Skin Prep with BPO | Experimental | Patients will undergo a skin cleansing protocols using 4% Chlorhexidine gluconate (CHG) cloths.
Following the CHG wipes, patients will be prepped with 5% BPO gel applied directly to the biopsy site.
After the skin prep, three 3-mm punch (Acu-Punch, Acuderm, Fort Lauderdale, FL) skin biopsies will performed for both an anterior-based hypothetical incision, and for a more lateral/posterior incision, for a total of 6 biopsies taken per subject. Receives: Drug: Benzoyl peroxide gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propionibacterium colinization rate on hips of healthy subjects
The rate at which Propionibacterium could be isolated from the skin of healthy subjects at locations corresponding to both the direct anterior and posterior surgical approaches with and without intervention.
Measured: Tissues samples taken at the time of surgery will be held for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start2 Feb 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Degenerative OsteoarthritisStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 - 4 %Chlorohexidine Wipe Group 2 - 4 % Chlorohexidine Wipe with 5% benzoyl peroxide (BPO) application
- Masking
- None (open label)
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Joint Replacement
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason M Jennings, MD DPT, Principal investigator, Colorado Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849885
- Sponsor's protocol ID
- 1378012
- Status last verified
- Jan 2023
- First submitted
- 20 Feb 2019
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data will be shared
Publications
Butler-Wu SM, Burns EM, Pottinger PS, Magaret AS, Rakeman JL, Matsen FA 3rd, Cookson BT. Optimization of periprosthetic culture for diagnosis of Propionibacterium acnes prosthetic joint infection. J Clin Microbiol. 2011 Jul;49(7):2490-5. doi: 10.1128/JCM.00450-11. Epub 2011 May 4.
PubMed 21543562Dizay HH, Lau DG, Nottage WM. Benzoyl peroxide and clindamycin topical skin preparation decreases Propionibacterium acnes colonization in shoulder arthroscopy. J Shoulder Elbow Surg. 2017 Jul;26(7):1190-1195. doi: 10.1016/j.jse.2017.03.003. Epub 2017 May 4.
PubMed 28479255Heckmann N, Sivasundaram L, Heidari KS, Weber AE, Mayer EN, Omid R, Vangsness CT Jr, Hatch GF 3rd. Propionibacterium Acnes Persists Despite Various Skin Preparation Techniques. Arthroscopy. 2018 Jun;34(6):1786-1789. doi: 10.1016/j.arthro.2018.01.019. Epub 2018 Mar 24.
PubMed 29580742Heckmann N, Sivasundaram L, Lieberman JR. Propionibacterium acnes Infection in the Native Hip: A Case Report. JBJS Case Connect. 2015 Jul-Sep;5(3):e60. doi: 10.2106/JBJS.CC.N.00192.
PubMed 29252848Holinka J, Bauer L, Hirschl AM, Graninger W, Windhager R, Presterl E. Sonication cultures of explanted components as an add-on test to routinely conducted microbiological diagnostics improve pathogen detection. J Orthop Res. 2011 Apr;29(4):617-22. doi: 10.1002/jor.21286. Epub 2010 Dec 7.
PubMed 21337398Hsu JE, Neradilek MB, Russ SM, Matsen FA 3rd. Preoperative skin cultures are predictive of Propionibacterium load in deep cultures obtained at revision shoulder arthroplasty. J Shoulder Elbow Surg. 2018 May;27(5):765-770. doi: 10.1016/j.jse.2018.01.021. Epub 2018 Mar 12.
PubMed 29544667Hudek R, Sommer F, Kerwat M, Abdelkawi AF, Loos F, Gohlke F. Propionibacterium acnes in shoulder surgery: true infection, contamination, or commensal of the deep tissue? J Shoulder Elbow Surg. 2014 Dec;23(12):1763-1771. doi: 10.1016/j.jse.2014.05.024. Epub 2014 Aug 29.
PubMed 25179369Koh CK, Marsh JP, Drinkovic D, Walker CG, Poon PC. Propionibacterium acnes in primary shoulder arthroplasty: rates of colonization, patient risk factors, and efficacy of perioperative prophylaxis. J Shoulder Elbow Surg. 2016 May;25(5):846-52. doi: 10.1016/j.jse.2015.09.033. Epub 2015 Dec 15.
PubMed 26704361Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2.
PubMed 22554729Lavergne V, Malo M, Gaudelli C, Laprade M, Leduc S, Laflamme P, Rouleau DM. Clinical impact of positive Propionibacterium acnes cultures in orthopedic surgery. Orthop Traumatol Surg Res. 2017 Apr;103(2):307-314. doi: 10.1016/j.otsr.2016.12.005. Epub 2017 Jan 5.
PubMed 28065868Lee MJ, Pottinger PS, Butler-Wu S, Bumgarner RE, Russ SM, Matsen FA 3rd. Propionibacterium persists in the skin despite standard surgical preparation. J Bone Joint Surg Am. 2014 Sep 3;96(17):1447-50. doi: 10.2106/JBJS.M.01474.
PubMed 25187583Levy 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 22981447MacNiven I, Hsu JE, Neradilek MB, Matsen FA 3rd. Preoperative Skin-Surface Cultures Can Help to Predict the Presence of Propionibacterium in Shoulder Arthroplasty Wounds. JB JS Open Access. 2018 Feb 16;3(1):e0052. doi: 10.2106/JBJS.OA.17.00052. eCollection 2018 Mar 29.
PubMed 30229238Nelson CL, McLaren AC, McLaren SG, Johnson JW, Smeltzer MS. Is aseptic loosening truly aseptic? Clin Orthop Relat Res. 2005 Aug;(437):25-30. doi: 10.1097/01.blo.0000175715.68624.3d.
PubMed 16056022Ong KL, Kurtz SM, Lau E, Bozic KJ, Berry DJ, Parvizi J. Prosthetic joint infection risk after total hip arthroplasty in the Medicare population. J Arthroplasty. 2009 Sep;24(6 Suppl):105-9. doi: 10.1016/j.arth.2009.04.027. Epub 2009 Jun 2.
PubMed 19493644
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03849885
- Acronym / sponsor ID
- 1378012
- Conditions
- Degenerative Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- Colorado Joint ReplacementUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Feb 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.
This study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called Propionibacterium, more specifically P acnes, the same bacterium that is responsible for the majority of acne. Information affecting hip surgery is currently unknown.
Detailed description
This study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called Propionibacterium. The most common bacterium of this family is P acnes, the same bacterium that is responsible for the majority of acne. There is increasing evidence that infection with P acnes and other Propionibacterium is a significant source of failure following certain orthopaedic shoulder procedures. However, information affecting hip surgery is currently unknown. Our personal experience leads us to believe that the numbers are actually quite high, since we are seeing an increased rate of Propionibacterium infection of hip replacement in the community. However, this type of study has never been done before, and therefore we simply do not know an accurate estimate for the average hip replacement patient's risk for Propionibacterium infection following hip replacement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1 - 4 %Chlorohexidine Wipe Group 2 - 4 % Chlorohexidine Wipe with 5% benzoyl peroxide (BPO) application
| Arm | Type | Receives |
|---|---|---|
| Standard Skin Prep | No intervention | –Patients will undergo a skin cleansing protocols using 4% Chlorhexidine gluconate (CHG) cloths. After the skin prep, three 3-mm punch (Acu-Punch, Acuderm, Fort Lauderdale, FL) skin biopsies will performed for both an anterior-based hypothetical incision, and for a more lateral/posterior incision, for a total of 6 biopsies taken per subject. |
| Experimental Skin Prep with BPO | Experimental | Drug: Benzoyl peroxide gelPatients will undergo a skin cleansing protocols using 4% Chlorhexidine gluconate (CHG) cloths. Following the CHG wipes, patients will be prepped with 5% BPO gel applied directly to the biopsy site. After the skin prep, three 3-mm punch (Acu-Punch, Acuderm, Fort Lauderdale, FL) skin biopsies will performed for both an anterior-based hypothetical incision, and for a more lateral/posterior incision, for a total of 6 biopsies taken per subject. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are 18 to 79 85 years of age
- CJR primary joint arthroplasty patients who are receiving care at Porter Adventist Hospital
- CJR established primary knee or hip arthroplasty patients with a native hip joint (no replacement on the biopsy side) who volunteers as a research participant.
- CJR patients without a previous arthroplasty procedure who have established care with our practice.
Key exclusion criteria (6 listed)
- Previous history of hip infection
- Current antibiotic use or antibiotic use within the past week
- Previous history of Cutibacterium joint infection
- Current immunodeficiency disease or disorder
- Patients with active psoriatic disease or other focal inflammation over the hip
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 |
|---|---|---|
| Benzoyl peroxide gelAlso: Acne MedicationSkin prep with Chlorohexidine wipes and BPO. | Drug | Experimental Skin Prep with BPO |
Primary outcome
Propionibacterium colinization rate on hips of healthy subjects
Time frame: Tissues samples taken at the time of surgery will be held for 14 days
The rate at which Propionibacterium could be isolated from the skin of healthy subjects at locations corresponding to both the direct anterior and posterior surgical approaches with and without intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 21543562Butler-Wu SM, Burns EM, Pottinger PS, Magaret AS, Rakeman JL, Matsen FA 3rd, Cookson BT. Optimization of periprosthetic culture for diagnosis of Propionibacterium acnes prosthetic joint infection. J Clin Microbiol. 2011 Jul;49(7):2490-5. doi: 10.1128/JCM.00450-11. Epub 2011 May 4.
- Background: PubMed 28479255Dizay HH, Lau DG, Nottage WM. Benzoyl peroxide and clindamycin topical skin preparation decreases Propionibacterium acnes colonization in shoulder arthroscopy. J Shoulder Elbow Surg. 2017 Jul;26(7):1190-1195. doi: 10.1016/j.jse.2017.03.003. Epub 2017 May 4.
- Background: PubMed 29580742Heckmann N, Sivasundaram L, Heidari KS, Weber AE, Mayer EN, Omid R, Vangsness CT Jr, Hatch GF 3rd. Propionibacterium Acnes Persists Despite Various Skin Preparation Techniques. Arthroscopy. 2018 Jun;34(6):1786-1789. doi: 10.1016/j.arthro.2018.01.019. Epub 2018 Mar 24.
- Background: PubMed 29252848Heckmann N, Sivasundaram L, Lieberman JR. Propionibacterium acnes Infection in the Native Hip: A Case Report. JBJS Case Connect. 2015 Jul-Sep;5(3):e60. doi: 10.2106/JBJS.CC.N.00192.
- Background: PubMed 21337398Holinka J, Bauer L, Hirschl AM, Graninger W, Windhager R, Presterl E. Sonication cultures of explanted components as an add-on test to routinely conducted microbiological diagnostics improve pathogen detection. J Orthop Res. 2011 Apr;29(4):617-22. doi: 10.1002/jor.21286. Epub 2010 Dec 7.
- Background: PubMed 29544667Hsu JE, Neradilek MB, Russ SM, Matsen FA 3rd. Preoperative skin cultures are predictive of Propionibacterium load in deep cultures obtained at revision shoulder arthroplasty. J Shoulder Elbow Surg. 2018 May;27(5):765-770. doi: 10.1016/j.jse.2018.01.021. Epub 2018 Mar 12.
- Background: PubMed 25179369Hudek R, Sommer F, Kerwat M, Abdelkawi AF, Loos F, Gohlke F. Propionibacterium acnes in shoulder surgery: true infection, contamination, or commensal of the deep tissue? J Shoulder Elbow Surg. 2014 Dec;23(12):1763-1771. doi: 10.1016/j.jse.2014.05.024. Epub 2014 Aug 29.
- Background: PubMed 26704361Koh CK, Marsh JP, Drinkovic D, Walker CG, Poon PC. Propionibacterium acnes in primary shoulder arthroplasty: rates of colonization, patient risk factors, and efficacy of perioperative prophylaxis. J Shoulder Elbow Surg. 2016 May;25(5):846-52. doi: 10.1016/j.jse.2015.09.033. Epub 2015 Dec 15.
- Background: PubMed 22554729Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2.
- Background: PubMed 28065868Lavergne V, Malo M, Gaudelli C, Laprade M, Leduc S, Laflamme P, Rouleau DM. Clinical impact of positive Propionibacterium acnes cultures in orthopedic surgery. Orthop Traumatol Surg Res. 2017 Apr;103(2):307-314. doi: 10.1016/j.otsr.2016.12.005. Epub 2017 Jan 5.
- Background: PubMed 25187583Lee MJ, Pottinger PS, Butler-Wu S, Bumgarner RE, Russ SM, Matsen FA 3rd. Propionibacterium persists in the skin despite standard surgical preparation. J Bone Joint Surg Am. 2014 Sep 3;96(17):1447-50. doi: 10.2106/JBJS.M.01474.
- 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.
- Individual participant dataSharing planned: No. No participant data will be shared
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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.
Jason M Jennings, MD DPT principal investigator
Colorado Joint Replacement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benzoyl peroxide gel in people with Degenerative Osteoarthritis, run by Colorado Joint Replacement at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 10 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roseann Johnson, BS CCRP (303-260-2940, roseannjohnson@centura.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propionibacterium colinization rate on hips of healthy subjects (time frame: Tissues samples taken at the time of surgery will be held for 14 days). 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 NCT03849885, which also lists 24 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 10 Jan 2023.