Trials / Completed
CompletedNCT03938467
Irrisept C.Acnes Study
Effect of Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate (Irrisept) on Incidence of Cutibacterium Acnes in Shoulder Arthroplasty
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Orthopaedic Associates of Michigan, PC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Antiseptic Cleanser | 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. |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2023-07-01
- Completion
- 2024-01-01
- First posted
- 2019-05-06
- Last updated
- 2024-06-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03938467. Inclusion in this directory is not an endorsement.