Surgiphor Us in TSA

Launched by ROTHMAN INSTITUTE ORTHOPAEDICS · Sep 16, 2024

Keywords

ClinConnect Summary

This study is testing whether cleaning the surgical wound during a first-time shoulder replacement with Surgiphor (sterile povidone-iodine) lowers the amount of bacteria and the chance of infection, compared with cleaning with plain sterile saline. It is a randomized trial, meaning participants are assigned by chance to receive one wash or the other, and it is open-label (the surgical team knows which wash is used). About 126 adults are being enrolled at Rothman Orthopaedic Institute in Philadelphia, and results are not yet available.

If you are eligible and choose to participate, you would be an adult (18 or older) undergoing elective primary total shoulder arthroplasty, able to provide written consent, and you must not have a prior shoulder surgery on the same shoulder, an iodine allergy, an active infection, or be in another clinical trial. During the operation, four wound swabs will be collected, and your shoulder will be washed with either sterile saline or Surgiphor before and after placing the implant. You’ll be followed for about 90 days after surgery to see if there are signs of infection or positive bacteria cultures. The study aims to help doctors know which washing method might better prevent infection after shoulder replacement.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults age \>18 years
• • Participants undergoing elective primary total shoulder arthroplasty
• • Participants willing to provide written consent
• Exclusion Criteria:
• • History of prior surgery to the operative shoulder
• • Known allergy to povidone iodine, iodine or shellfish
• • active clinical infection
• • participation in other clinical trials