Four hospitals from different Spanish autonomous regions take part in this clinical study.
IBSAL, as a space devoted to biomedical research, fulfils its commitment to encourage collaboration and cooperation with other centres and research groups with a new healthcare product clinical trial titled: “Ensayo Clínico fase III prospectivo, multicéntrico, abierto, aleatorizado de prevención de la fuga aérea postoperatoria tras resección pulmonar en pacientes de riesgo elevado, mediante la aplicación de HEMOPATCH®” (HEMOPATCH® for the prevention of postoperative air leaks after pulmonary resection in high-risk patients: a prospective, multicentre, open and randomised phase III clinical trial).
IBSAL, as host organisation, accepted a few months ago the project's proposal and principles from the researchers of the Thoracic Surgery Department of the University Hospital of Salamanca, Dr Varela and Dr Jiménez. The Institute offers the necessary channels to manage all the activities involved in the set up, development and fulfilment of a clinical trial that has the added complexities of a multicentre study.
The study emerges from the existence of a very common problem, postoperative prolonged air leaks, which currently cannot be treated. Prolonged air leaks can cause pain, anxiety and stress for the patient, while also increasing the risk of other cardiorespiratory complications. They also entail a significant increase in costs for the healthcare system, as they are the reason behind longer hospital stays. The aim of this study is to develop a therapeutic solution for patients at risk of suffering this condition by applying a collagen pad called Hemopatch®. Hemopatch® is a healthcare product available in Spain, CE-marked and authorised for other other indications in the past, but also CE-marked for this new use.
The clinical study is taking place in four hospitals from different Spanish autonomous regions: San Carlos Hospital in Madrid, Hospital Clinic in Barcelona, Virgen del Rocío Hospital in Seville and the University Hospital of Salamanca, this last one in charge of coordinating the trial. Thirty-three patients have been included in the trial, which is expected to end by May 2017.