(CR-051) A Prospective, Multi-centre, Post-market Clinical Follow-up Study to Evaluate the Safety and Effectiveness of a Three-layer Silicone Adhesive Foam Dressing
Introduction: Both chronic and acute wounds require suitable management with an appropriate dressing to ensure the healing process occurs effectively1.
The primary objective of this (post market clinical follow up (PMCF) study is to demonstrate the clinical performance of a three layer silicone adhesive foam dressing as measured by reduction in the size of the wound area (cm2) over a 4-week treatment period, in subjects with chronic and acute wounds. In addition to the reported primary and secondary endpoints, the overall benefits observed for patients, with specific focus on 7 patient case studies reported.
Methods: Between March 2019 and November 2021, forty eligible patients across 6 sites with either a chronic or acute wound, were enrolled in a prospective, single-arm, clinical study. Patients received treatment with a foam dressing for up to 4 weeks. Outcomes reported included: the change in wound size, dressing wear time, and patient reported outcomes.
Results: Wounds treated in the modified Intention to Treat (mITT) study population demonstrated a significant median area reduction of 2.2 cm2 from baseline to 28 days (p=0.002) and a significant percentage median area reduction of 47.0% (p< 0.001). Exudate levels were managed effectively, with a reported mean wear time of 4.5 days. Patients experienced a positive impact on their overall quality of life and wellbeing from baseline study visits to end of treatment. This PMCF study supports the use of a three-layer silicone adhesive foam dressing and has demonstrated its safe and effective use in the management of chronic and acute wounds.
Discussion: The use efficacy and safety of a three-layer silicone adhesive foam dressing for the management of both acute and chronic exuding wounds has been demonstrated by the PMCF clinical study.
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