1. Wound Imaging & Measurementfor Clinical Research& Clinical PracticeComparing the optionsDr. Mark Nixon

2. Learning outcomes covered Why wound measurement is important Traditional wound measurement methods theadvantages and the disadvantages 3D wound imaging systems An example of 3D electronic wound measurement 3. Measurement is importantfor clinical trials Measurements and healing rates are involved ininclusion/exclusion criteria Healing rates may be used as secondary end-point Wound measurement is an important part of sourcedocumentation Inadequate documentation should never be areason for trial failure 4. Measurement is importantfor clinical practice Assessing healingtrends Predicting outcomes Monitoring the effectof treatment Clinical decisionsupport Development of bestpractice protocols Improving patientcompliance Reimbursement Risk management suchas litigation defence 5. Traditional measurement Rulers Acetate tracing Digital cameras / digital planimetry 6. Area measurements using rulers Length and width measurements often used todetermine an area true area of the wound (cm2)Length (l)Width (w) 7. A valid index can demonstrate a trend An analogy: The Dow Jones Industrial Average is anindex whose value is taken to represent an entirestock market It is an indicator not the stock market itself But there exists a relationship between the stockmarket and the index It can track the market's changes over time 8. Is an indicatorfor a wounds area?length (l)length (l)width (w) length (l)width (w) ? 9. How reliable is an area index?It is difficult for the same user, let alone different users,to obtain the same measurements 10. How reliable is an area index?Errors accumulate in ruler-based area measurementslength, width 10 cmarea = 100 cm2length, width + 10%area = 121 cm2 an error in 10% of length and 10% of width results in an error in area of 20% 11. Depth/volume inaccuracy Change in depth is an important indicator Some calculate as a volume index A depth probe like a Q-tip is not accurate So a volume index ( ) calculation is even lessreliable than an area index 12. is not to wound arealength (l)length (l)width (w) width (w)length (l) 13. Is planimetry the answer?Planimetry noun (mathematics): the measurement ofarea on a surface Acetate tracing methods is the traditional goldstandard for making area measurements Takes curvature of the anatomy into account But messy, uncomfortable, increased risk of infection Digital planimetry: the best of both worlds? 14. Requirements of digital planimetry1. The wound lies in a flat plane2. There is a scaled target that is also in a plane3. The wound and the target are in the same plane4. The camera lens is parallel to the wound and the target 15. Requirements of digital planimetryAttempts to combine digital photography with woundmeasurement are at risk of being inaccurate and unreliable. 16. Documentation & digital photography Multiple opportunities tocompromise documentation Feature-laden digital cameras Out of focus Poor illumination Obscured Improper annotation Unrecognizable location Local storage and security (HITECH) Transfer to EMRImage out offocus, badlyexposedObstructed byscaleOut of focus,backgroundclutterWound out offocus, badlyexposedDigital Photography Handbook, Wounds West, 2010 17. 3D wound imaging methods1. Structured light projection, such as laser triangulation 3D wound model created from laser lines Image provides visual reference2. Photogrammetry determining the geometric properties of wound from multiple photographic images 18. Advantages of 3D wound systems Capture a 3D description of wound and surrounding anatomy No target (e.g. ruler) is required Quantities such as area, perimeter, depth and volume can bedetermined directly from the 3D model Data is in electronic format (allowing EMR integration / enterprise-widewound analytics)Limitations of 3D wound systemsSome of the issues with traditional measurements remain: Unable to quantify undermining Circumferential wounds can be more challenging Some user interpretation of the measurements still required 19. An Example: The Silhouette 3D woundmeasurement, imaging anddocumentation system 20. Silhouette 21. Silhouette 22. Silhouette 23. Silhouette 24. Silhouette 25. Silhouette 26. Silhouette Proven in clinical trials and clinical practice Captures and stores medical digital images Creates a 3D model of the wound Measures accurate area, depth and volume studies have shown accuracy to within 2% for area, 1% for perimeterand 5% for depth and volume on wound models Reliably tracking healing over time Centralized database can be accessed remotely Secure, encrypted, auditable Regulatory clearance including FDA 27. 1. Capture ofquality data withSilhouette point-of-care devicesThe power of evidence3. Development ofevidence-based carepathways andimplementation intoSilhouettes protocol2. Data analysiswith Silhouettesaggregatereporting engineengine Accurately measure anddocument wounds Data is stored electronically Transform wound carepractice Better-informed decisionmaking Better experience forpatients and staff 28. Practicable Measurement Imaging Documentation= good = maybe = not applicableRulerAcetate tracingDigitalplanimetry3DSummary 29. References Bargaje, C. Good documentation practice in clinical research. Perspect. Clin Res. 2011 Apr-Jun; 2(2); 59-63. Dowsett C, Use of TIME to improve community nurses wound care knowledge and practice. (2009) Wounds UK5(3): 1421 Dinh et al, Global Perspective on Diabetic Foot Ulcerations 2011 Fletcher, J.; The use of electronic data capture devices in wound care settings. Wounds UK 2012, Vol 8, No 4. Gethin G, Cowman S (2005) Comparison of acetate tracing and digital planimetry to obtain area measurement ofsuperficial leg ulcers. Poster presented at Wounds UK Conference, Harrogate: 14-16 November 2005 Gethin, Wounds UK, 2006,Vol 2, No 2 Rennert, Robert BA; et al, Standardization of Wound Photography Using the Wound Electronic Medical Record,Salcido, Richard MD, Beyond Photography: Wound Imaging , Advances in Skin and Wound Care, Feb 2011 Schultz G, Mozingo D, Romanelli M, Claxton K (2005) Wound healing and TIME: new concepts and scientificapplications. Wound Repair Regen 13(4 Suppl): S1S11 1 U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation andResearch (CDER); Guidance for Industry Acute Bacterial Skin and Skin Structure Infections: Developing Drugs forTreatment, August 2010, Clinical/Antimicrobial, Revision 1. Warren, Joan; In Focus: Uses and Limitations with using Digital Photography for Pressure Ulcer Staging in theAcute Care Setting 2012 Wendelken,E. et al; Wounds Measured From Digital Photographs Using Photodigital Planimetry Software -Validation and Rater Reliability, Martin Wounds. 2011;23(9):267-275.