Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Safety evaluation: 1.Adverse clinical events (type, duration, seriousness, result and causality relation) by means of interrogation, and general and local physical examination. Measurement time: 24 hours, 48 hours and at 10 days post-leaving. 2.Haemostasis: Haemostatic parameters (thrombin time, fibrinogen and degradation products of fibrin/fibrinogen -PDF). Measurement time: 24 and 48 hours. 3.Immunogenicity: Presence of anti-streptokinase antibodies. Measurement time: 10 days from leaving.
Key secondary outcomes:
1.Pain: measured by a visual analogous scale. 2.Œdema: evaluated by its presence or not at the direct physical examination (inspection) of the region. 3.Lesion size: indirect and objective measure of the oedema evolution. The patient was placed in decubitus prone with exposure of the anal part and measured in centimetres, at the beginning, 24 and 48 hours, the larger horizontal and vertical diameters of the lesion.