Patient eligibility criteria for a surgical treatment that enhances tissue sealing by use of a medicated sponge: observational study ELITE.

ABSTRACT

RATIONALE The application of a haemostatic agent in general surgery, in addition to its effect on bleeding, also provides tissue sealing and adhesion. A sponge drug is used with some actions of resection and wide dissection, without knowledge of the eligibility of patients. In this study, we sought to identify clusters of patients for which the medicated sponge enhances tissue sealing. METHODS: Observational study (ELITE), from a panel of selected surgeons from hospitals in France in several surgical areas abdominal, gynaecology, urology and thoracic. The survey identified the criteria for using the sponge TachoSil® in their surgical practices involving n = 683 patients. A multiple correspondence analysis (MCA) followed by an ascending hierarchical classification (AHC) was used in order to identify the eligibility criteria for the application of the sponge for tissue sealing in addition to hemostasis. RESULTS: The most relevant classification was based on 9 groups of patients for which the sponge was used. 6 of them are mainly linked with the kind of lesion, 2 with the site of application and the latest one with the type of operation. CONCLUSIONS: The ELITE study revealed that the TachoSil® sponge was used mainly during surgery, requiring a reinforcement of the resection tissue sealing. The expected objective was successfully reached in 97% of the cases.