A Phase 4 interventional study of Benzoyl peroxide gel in Degenerative Osteoarthritis, sponsored by Colorado Joint Replacement. Status unknown at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-10.
Sponsored by Colorado Joint Replacement · Phase 4, Interventional, and Diagnostic
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.
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.
716 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's planned enrollment of 496 is above the median of 60 across 473 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →Colorado Joint Replacement is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
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.
Drug: Benzoyl peroxide gel
Skin prep with Chlorohexidine wipes and BPO.
Also known as: Acne Medication
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.
Time frame: Tissues samples taken at the time of surgery will be held for 14 days
Plan to share: No — No participant data will be shared
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Benzoyl Peroxide
Colorado Joint Replacement