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Do Wound Protectors Reduce Contamination in Total Shoulder Arthroplasty?

NCT06513182 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-29

No results posted yet for this study

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 investigative research on the use of a wound protector in shoulder arthroplasty, specifically with an ability to decrease wound contamination. The investigators primary purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of bacteria in primary shoulder arthroplasty. A secondary purpose is to evaluate if the wound protector decreases soft tissue trauma during total shoulder arthroplasty.

Conditions

  • Cutibacterium Acnes

Interventions

OTHER

No Alexis orthopaedic protector

No Alexis orthopaedic protector will be used during the course of the surgery.

DEVICE

Alexis orthopaedic protector

Alexis orthopaedic protector will be inserted after making an initial superficial approach to the shoulder.

Sponsors & Collaborators

Principal Investigators

  • Christopher Joyce, M.D. · University of Utah Orthopaedics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-21
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06513182 on ClinicalTrials.gov