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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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States, 19107