for clinical research

Organizations conducting clinical trials on wound care and wound care products can measure wounds and track wound healing progression in a way that is quick, accurate, user-independent, secure and accessible. Data is collected efficiently from multiple research sites and centralized.

Silhouette is the wound assessment solution choice for a number of clinical studies in the United States and more than 15 other countries worldwide. Studies are multi-center and multi-national.

ARANZ Medical provide a variety of services for organizations conducting clinical trials including training, customer support and customization. Please enquire directly to see whether Silhouette is the solution for your next clinical trial.

Types of Clinical Trials currently using Silhouette

• Studies range from pre-clinical to Phase III. Trials are most commonly Phase II and Phase III
• Ulcer research including Venous Leg Ulcers (VLU), Diabetic Foot Ulcers (DFU) and Pressure Ulcers
• Agents assessed include biological, pharmaceutical, dressing and medical device products
• Clinical trials range in size from 1 to 150+ investigator sites
• The majority of larger trials are FDA approved
• Studies assessing ABSSSI (Acute Bacterial Skin and Skin Structure Infections) or as previously categorised Complicated Skin and Skin Structure Infections (cSSSI) and Uncomplicated Skin and Skin Structure Infections (uSSSI). New draft FDA guidelines propose study inclusion criteria include infected skin areas that measure a minimum redness and/or induration of 75 cm² (or 15 cm in length by 5 cm in width)¹.

The Silhouette Product Suite seamlessly integrates the flow of data to enable efficient collection of electronic data from multiple research sites at the time of patient assessment - improving the efficiency of data collection, providing more complete, consistent and accurate records.

SilhouetteMobile™ is the point-of-care data collection tool for the product suite. SilhouetteMobile features include:

• Multiple tools in one - imaging, measurement and documentation
• Repeatable and accurate measurements
• Measures area, depths, height and estimates volume
• Highly portable and non-contact
• Automatic report generation
• Track wound healing over time
• Quick and easy to use
  

Key Features and Benefits of Silhouette

• Training is minimal. In less than 2 hours, users are confident in operating SilhouetteMobile.
• Data collection is quick and efficient. In less than 3 minutes a clinician can capture an image, and perform an area and depth assessment.
• Measurements are repeatable and accurate. Have confidence in the accuracy of tracking wound healing over time, even with different users. With SilhouetteMobile’s Smart Calibration technology to unwrap the skin’s curvature, measurements are significantly more accurate than other methods.
• Data is immediately accessible for study administrators via the internet.
• Robust, automated and seamless information transfer. At the touch of a button information is sent to the data manager, SilhouetteCentral™ for long-term storage and review from anywhere in the world.
• Study data is easily exported into a standard format for further analysis and statistical processing.
• Functionality for Part 21CFR11 compliance including system access password control, data encryption and audit logging of user activities.

Ask about Silhouette’s Protocols

Protocols help guide a user through a workflow to capture data and can be customized specifically for a clinical study.

To talk to a Silhouette sales representative, please contact us to complete the enquiry form.

References