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Researchers are examining hypergranulation (HG), a common barrier to wound healing, by evaluating a new Hypergranulation Tool designed to standardize wound assessment. This observational study involves 80 to 100 adult and pediatric patients in the United Kingdom with HG present in venous leg ulcers or complex surgical wounds. The study aims to test the performance of this tool by comparing it to three-dimensional wound photographs and patient-reported outcomes, helping to validate its clinical use and inform future intervention trials. Participants will attend 2 to 4 clinic visits where nurses will use the Hypergranulation Tool Proforma to assess wounds based on five specific parameters, grading HG severity as mild, moderate, or severe. Alongside this, a device will be used to capture 2D wound images that construct 3D models to measure hypergranulation volume and affected area. Validated patient-reported outcome forms and exit interviews will also collect data to support the tool's evaluation. Throughout the study, wound assessments, 3D imaging, and patient questionnaires will be completed at each visit to monitor wound healing and tool accuracy. The primary outcome measures the effectiveness of 3D photography as a tool for assessing HG tissue compared to the clinical Hypergranulation Tool. The study includes participants aged 2 to 85, with follow-up over multiple visits to track wound progress and collect comprehensive clinical and patient-reported data by August 2026.

Age: 2Years - 85YearsAll Genders
1 location
Ellesmere Port Clinical Trials | DecenTrialz