Status:
ENROLLING_BY_INVITATION
Surgiphor Us in TSA
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Total Shoulder Arthroplasty
Shoulder Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Bacteria is occasionally present in the shoulder during shoulder arthroplasty surgery and is hypothesized to increase the risk of failure of the prosthesis. Surgiphor (sterile Povidone-Iodine) wound i...
Detailed Description
The purpose of this study is to determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total sho...
Eligibility Criteria
Inclusion
- Adults age \>18 years
- Participants undergoing elective primary total shoulder arthroplasty
- Participants willing to provide written consent
Exclusion
- History of prior surgery to the operative shoulder
- Known allergy to povidone iodine, iodine or shellfish
- active clinical infection
- participation in other clinical trials
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06601803
Start Date
September 16 2024
End Date
September 30 2025
Last Update
September 19 2024
Active Locations (1)
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1
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107