Wound Protectors for Shoulder Replacement Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the Alexis orthopaedic protector can prevent infections during shoulder replacement surgeries. The focus is on reducing bacteria in the wound and minimizing soft tissue damage. Participants will either use a wound protector during surgery or not. Ideal candidates are those undergoing their first shoulder replacement surgery with specific surgeons. Individuals with previous shoulder infections or those unable to consent are not eligible. As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical outcomes for future patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this wound protection device is safe for shoulder arthroplasty?
Research has shown that the Alexis orthopaedic protector can make surgeries safer by lowering the risk of infections. In one study, the rate of surgical site infections dropped from about 23% to just under 5% with the protector. This indicates it helps prevent germs from entering the wound.
The Alexis orthopaedic protector also shields soft tissues like skin and muscles from damage during surgery, protecting the area from rough tools and debris. Evidence suggests that this protector can reduce the chance of developing thick, raised scars after surgery.
Overall, these studies suggest that the Alexis orthopaedic protector is a safe and effective way to reduce infections and protect tissues during shoulder surgery.12345Why are researchers excited about this trial?
Researchers are excited about using the Alexis orthopaedic protector in shoulder replacement surgery because it offers a potential new way to reduce the risk of wound infections. Unlike the traditional approach where no protective barrier is used, this wound protector acts as a physical shield, potentially minimizing bacterial contamination during surgery. This could lead to fewer post-surgical infections and quicker recovery times, making a big difference for patients undergoing this common procedure.
What evidence suggests that the Alexis orthopaedic protector is effective for reducing wound contamination in shoulder arthroplasty?
This trial will compare the use of the Alexis orthopaedic protector with a control group that does not use the protector during shoulder replacement surgery. Studies have shown that the Alexis orthopaedic protector can reduce the risk of bacterial contamination during surgery. Research indicates that this device may lower the presence of P. acnes, a type of bacteria, in surgical wounds. Initial findings suggest it also protects the wound and may prevent complications like infections. Although limited research exists specifically on shoulder surgeries, the device has proven useful in other surgeries by reducing infection risk. Overall, evidence suggests that the Alexis protector is a promising tool for maintaining clean and safe surgical areas.36789
Who Is on the Research Team?
Christopher Joyce, M.D.
Principal Investigator
University of Utah Orthopaedics
Are You a Good Fit for This Trial?
This trial is for individuals undergoing primary shoulder arthroplasty, aiming to see if using a wound protector can reduce deep wound bacterial contamination and soft tissue trauma during surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo shoulder arthroplasty with or without the use of a wound protector. Tissue swab cultures are obtained during surgery.
Follow-up
Participants are monitored for positive C acnes culture results and any signs of infection.
What Are the Treatments Tested in This Trial?
Interventions
- Alexis orthopaedic protector
Trial Overview
The study compares the effectiveness of an Alexis orthopaedic protector versus no protector in preventing joint infection after shoulder replacement surgery. Participants will be divided into two groups to assess differences in outcomes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
Citations
use of a wound protector: Minimizing P. acnes contamination
The aim of this prospective, clinical study was to determine whether the use of a wound protector drape can lower the incidence of P. acnes in the wound during ...
2.
researchgate.net
researchgate.net/figure/Proprietary-photograph-of-the-Alexis-Wound-Protector_fig1_327804957Proprietary photograph of the Alexis Wound Protector.
Additionally, only one study has reported the usefulness of protectors in preventing infection in the shoulder joint, but no studies have investigated the use ...
Alexis® Orthopedic Protector Provides Wound Protection ...
The surgical approach, prosthesis model, operative time, blood loss, and length of hospital stay were investigated. Clinical findings were.
Shoulder arthroplasty in the management of native ...
Shoulder arthroplasty in the management of either primary or secondary native shoulder infections has a high complication rate and low functional outcome
5.
journaloei.scholasticahq.com
journaloei.scholasticahq.com/article/67844-optimizing-outcomes-in-shoulder-arthroplasty-mitigating-surgical-complications-in-high-risk-patients-case-reportOptimizing Outcomes in Shoulder Arthroplasty
“Optimizing Outcomes in Shoulder Arthroplasty: Mitigating Surgical Complications in High-Risk Patients – Case Report.” Journal of Orthopaedic ...
Alexis®
“There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used: 3 of 64 (4.7%) vs 15 of 66 (22.7 ...
Alexis® Orthopedic Protector Provides Wound Protection ...
Alexis® Orthopedic Protector is expected to provide wound protection. Comparisons of postoperative results between patients with and without ...
Alexis Orthopaedic Protector
The Alexis orthopaedic protector shields soft tissue – including skin, fat, muscles and nerves – from contact with abrasive instrumentation and debris at the ...
Alexis® Orthopedic Protector Provides Wound Protection ...
Alexis® Orthopedic Protectors can not only provide short-term wound protection but also reduce the rate and degree of hypertrophic scarring.
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