Assessment of the efficacy of a novel adhesive haemostat using real world, case series data collection

Abstract

BackgroundPost-operative haemorrhage can lead to significant complications and even mortality. These utilise scarce healthcare resources and increase hospital costs, as well as negatively impacting on patient's quality of life. Haemostats that exhibit additional adhesive properties can reduce the rate of bleeding complications. Standard gelatin sponges have been used safely in surgery for over 75 years but have almost no adhesive properties. This article reports the performance of a novel adhesive gelatin patch in human surgery for the first time. MethodsA CE-marked gelatin foam patch (TenaTac®, Selentus Science, UK) has been created through a physical modification of the sponge surface, avoiding the need for the addition of blood-derived components or additional chemicals to stimulate adhesion. Real-world, post-approval clinical evaluations of the device were undertaken, and a structured data form was utilised to collect information on the device's performance during these procedures. ResultsIn total, 63 evaluations were undertaken by 40 surgeons in 13 countries, covering 29 different surgical procedures. When assessing the adherence of TenaTac, 83 % (48/58) of the surgeons assessed the adhesion as very good or excellent. Both “haemostatic effect” and “time to haemostasis” achieved median scores of 4/5 (IQR 4–5), which equated to “very good” on the questionnaire. When surgeons were asked to compare their experience with TenaTac against their usual haemostat, 91.7 % (55/60) rated it as good, very good or excellent. When surgeons were asked if they would recommend the use of TenaTac, 96.5 % (55/57) of the surgeons responded positively to this question. ConclusionReal world evaluation of the novel adhesive patch, TenaTac, has confirmed that it exhibits very good adhesive and haemostatic qualities and could be considered for use by a wide variety of surgical specialities.