Status:

ACTIVE_NOT_RECRUITING

Do Wound Protectors Reduce Contamination in Total Shoulder Arthroplasty?

Lead Sponsor:

University of Utah

Conditions:

Cutibacterium Acnes

Eligibility:

All Genders

40-90 years

Phase:

NA

Brief Summary

Prosthetic joint infection is a devastating complication of shoulder arthroplasty. A relatively novel method of preventing PJI has been with the use of a wound protection device. There is minimal inve...

Detailed Description

Prosthetic joint infection (PJI) is a relatively uncommon but devastating complication of shoulder arthroplasty. Published rates of PJI after shoulder arthroplasty range one to ten percent. Since the ...

Eligibility Criteria

Inclusion

  • Patients undergoing primary anatomic or reverse shoulder arthroplasty by one of three surgeons will be eligible.

Exclusion

  • revision arthroplasty,
  • history of ipsilateral shoulder infection,
  • patients unable or unwilling to consent,
  • prisoners,
  • pregnant individuals,
  • mentally disabled patients,
  • employees of the University of Utah,
  • allergy to polyurethane polyester.

Key Trial Info

Start Date :

June 21 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2029

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06513182

Start Date

June 21 2024

End Date

June 1 2029

Last Update

October 29 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Utah Orthopedics

Salt Lake City, Utah, United States, 84108