Do Wound Protectors Reduce Contamination in Total Shoulder Arthroplasty?

NCT06513182 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 179068
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Keywords

Total shoulder arthroplasty; Wound protector; Cutibacterium acnes; Contamination

Outcome Measures

Primary Outcomes (1)

• Positive C acnes culture

  The primary outcome of the study will be percent of positive C acnes culture results.

  2-weeks

Study Arms (2)

Control - no wound protector

OTHER

The (control - no wound protector) will not use the protector device during the course of the surgery. During surgery 4 tissue swab cultures will be obtained and sent to a laboratory for analysis.

Other: No Alexis orthopaedic protector

Wound protector

EXPERIMENTAL

Wound protector group will have an insertion of a wound protector after making an initial superficial approach to the shoulder. During surgery 4 tissue swab cultures will be obtained and sent to a laboratory for analysis. The wound protector will then remain in place until the end of the case during wound closure.

Device: Alexis orthopaedic protector

Interventions

No Alexis orthopaedic protector OTHER

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

Control - no wound protector

Alexis orthopaedic protector DEVICE

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

Also known as: Wound protector, Rigid Retraction Ring, Flexible Retraction Ring

Wound protector

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

Location

Study Officials

• Christopher Joyce, M.D.

  University of Utah Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 22, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)