{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T21:43:05Z","timestamp":1791495785385,"version":"4.3.4"},"reference-count":0,"publisher":"HMP Communications, LLC","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Wounds"],"abstract":"<jats:p>Background. A key element in achieving high-quality research lies in the use of validated tools for effective data collection. To enhance this process, the authors have created comprehensive reporting guidelines for these essential tools. Objective. As members of the Wound Care Collaborative Community (WCCC) Tools Work Group, to identify tools capable of measuring percentage area reduction (PAR) and\/or percentage volume reduction (PVR) and to assess the various features associated with these wound imaging devices. Methods. Data from publicly available databases and surveys of manufacturers meeting the inclusion criteria were collected in the fourth quarter of 2023 and the second quarter of 2024. The inclusion criteria were medical devices with the US Food and Drug Administration (FDA) FXN (Tape, Camera, Surgical) product code classification capable of length and width wound measurements currently marketed by FDA-listed establishments. Results. Thirteen FDA-registered establishments with 14 wound imaging devices met the inclusion\/exclusion criteria. Representatives from 10 of those establishments engaged in the survey process by completing and returning their WCCC questionnaires. Seven tables were created to summarize the findings across the devices. Conclusion. More wound imaging devices measure PAR than PVR, and most utilize the perimeter alone or in conjunction with square surface area and\/or oval or other shapes for area calculations. While variations in length or width (up to 5%), and area (up to 10%) may occur with the device calculations, these variations are less than is seen with ruler measurements. Several imaging devices incorporate methods to correct for skew, have sophisticated 3-dimensional modeling, and\/or use reference markers to enhance overall accuracy and reliability, supporting their measurements as reliable indicators of wound trajectory.<\/jats:p>","DOI":"10.25270\/wnds\/24201","type":"journal-article","created":{"date-parts":[[2025,6,24]],"date-time":"2025-06-24T17:01:46Z","timestamp":1750784506000},"page":"210-219","source":"Crossref","is-referenced-by-count":2,"title":["An Overview and Survey of US Food and Drug Administration\u2013Registered Wound Imaging Devices Capable of Determining Percentage Area Reduction and\/or Percentage Volume Reduction"],"prefix":"10.25270","volume":"37","author":[{"given":"Holly","family":"Korzendorfer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peggy","family":"Dotson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis","family":"James","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Windy","family":"Cole","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alisha","family":"Oropallo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10906","published-online":{"date-parts":[[2025]]},"container-title":["Wounds: a compendium of clinical research and practice"],"original-title":[],"deposited":{"date-parts":[[2025,6,24]],"date-time":"2025-06-24T17:01:47Z","timestamp":1750784507000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.hmpgloballearningnetwork.com\/site\/wounds\/original-research\/overview-and-survey-us-food-and-drug-administration-registered-wound"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025]]},"references-count":0,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2025]]}},"URL":"https:\/\/doi.org\/10.25270\/wnds\/24201","relation":{},"ISSN":["1943-2704"],"issn-type":[{"value":"1943-2704","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025]]}}}