Proven wound care evidence for Clinical Research

Delivering the evidence you need for a successful trial.

Silhouette® is an easy to use wound imaging, 3D measurement, and documentation system using non-invasive laser technology. As an FDA approved medical device, Silhouette has been proven to provide accurate, precise, and repeatable wound assessments for all phases of clinical research in more than 70 studies globally.

High Quality Data

Easy to Use

Proven

Benefits

Risk Mitigation

Proven
Risk Mitigation

FDA approved Silhouette is the gold standard for reliable, credible evidence. The Silhouette system ensures study data is anonymous, private, and secure, mitigating risks to your study and business. Audit trails are available to track Silhouette hardware and software usage.

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Efficiency

Proven
Efficiency

Silhouette’s pioneering wound assessment workflow supports investigators in delivering precise evidence that is instantly available to Sponsors and CROs. Corrections can be made instantly in the event of errors, and subjects can be excluded if they no longer meet trial criteria.

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Precision

Proven
Precision

Studies show that any single Silhouette-derived measurement is within approximately 2% for Area, 1% for Perimeter, 5% for Average Depth, and 5% for Volume. (95% confidence interval)

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Successful Outcomes

Proven
Successful Outcomes

Silhouette data has supported numerous pre-clinical and Phase I-IV trials to successful outcomes, including progressions through all phases to successful FDA approvals, progression through funding stages, and acceptance of research by peer-reviewed and respected international journals.

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Repeatability

Proven
Repeatability

With Silhouette, all evidence gathered is transparent and repeatable. Inter- and intra-rater variability is extremely low - <1% for area and perimeter, and <2% for average depth and volume.

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Advanced Image Capture

Proven
Advanced Image Capture

The world’s easiest-to-use wound camera, SilhouetteStar guides the user to focus the camera with laser lines, and consistently lights each wound using LEDs. Structured light software builds a 3D model of the wound.

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Data Security and Privacy

Proven
Data Security and Privacy

Silhouette supports the privacy and security compliance required by HITECH and HIPAA. Data is instantly integrated into the research notes and removed from the camera to the Silhouette software after the wound has been imaged. Silhouette ensures that all research data is anonymous, preventing any possibility of a privacy breach.

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Services and Support

Proven
Services and Support

Wherever a wound is being assessed, a comprehensive services and support portfolio is available. Our experienced Services team offers comprehensive implementation, project management, customization, configuration, training, hardware and software support, as well as maintenance services including second-tier support for both users and administrators.

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