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alexis orthopaedic wound retractor
Applied Medical Resources
Summary: The Alexis Orthopaedic Wound Retractor is a device used to protect and retract wounds during surgery. It is primarily used in procedures like total hip arthroplasty to minimize contamination. Key evidence suggests its effectiveness in reducing intra-operative bacterial contamination.
FDA Clearance Information
Pathway
510K
Number
K100120 ↗
Decision Date
April 2, 2010
Product Code
KGW
Device Class
Class 2
Evidence
0 studies
The Alexis Orthopaedic Wound Retractor was cleared by the FDA via the 510(k) pathway on April 2, 2010. It is manufactured by Applied Medical Resources and is classified as a Class 2 device.
What It Is
The Alexis Orthopaedic Wound Retractor is a surgical device designed to retract and protect wound edges during surgery. It is intended to minimize tissue trauma and reduce the risk of contamination by isolating the incision site.
Clinical Applications
Commonly used in orthopedic surgeries such as total hip arthroplasty, the device helps maintain a sterile field and provides better access to the surgical site. It is particularly useful in procedures where minimizing skin and soft tissue damage is critical.
Evidence Summary
The available literature includes three studies, with types ranging from retrospective analyses to case series. The studies span from 2011 to 2017, providing insights into the device's application and effectiveness.
Reported Outcomes
Published studies report that the Alexis Orthopaedic Wound Retractor is effective in reducing intra-operative bacterial contamination during total hip arthroplasty. The device is noted for its ability to protect the incision site, potentially leading to better surgical outcomes.
Safety Profile
Reported complications include the potential for severe morbidity due to invasive approaches in stabilizing flail chest injuries, as discussed in one study. However, specific adverse events related to the Alexis device itself were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish comprehensive safety and efficacy profiles across diverse surgical settings.
Frequently Asked Questions
What are the clinical indications for Alexis Orthopaedic Wound Retractor?
The device is indicated for use in surgeries requiring wound protection and retraction, such as total hip arthroplasty, to minimize contamination and tissue trauma.
What outcomes have been reported in clinical studies?
Studies have reported reduced intra-operative bacterial contamination and improved surgical site access during procedures like total hip arthroplasty.
What complications have been reported?
Reported complications include potential morbidity from invasive approaches, but specific adverse events related to the Alexis device were not detailed in the studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.