International Scholarly Research Notices / 2012 / Article / Tab 2 / Clinical Study
Efficacy and Tolerability of Clarema 1% Cream and Hirudoid 40000 U.APTT Gel in the Topical Treatment of Haematomas and/or Subcutaneous Haematic Extravasations Table 2 Subjective symptoms and objective signs of haematomas/extravasations (secondary efficacy variables).
(a) Parameter Mean decrease from baseline to endpoint Mean [95% CI] Differences between the adjusted means [95% CI] Heparan sulfate GAGPS Pain at rest −1.2 [−1.4 to −1.1] −1.1 [−1.3 to −1.0] 0.02 [0.07 to 0.11] Pain on movement −1.9 [−2.0 to −1.7] −1.4 [−1.6 to −1.1] 0.53 [0.27 to 0.78] Functional disability −1.6 [−1.8 to −1.4] −1.3 [−1.5 to −1.1] 0.39 [0.09 to 0.68] Oedema −2.3 [−2.5 to −2.1] −1.9 [−2.2 to −1.7] 0.41 [0.19 to 0.63] Colour of the lesion −2.8 [−2.9 to −2.7] −2.1 [−2.3 to −2.0] 0.64 [0.42 to 0.87] Size of the lesion Minimum diameter −5.1 [−5.8 to −4.5] −3.9 [−4.6 to −3.2] 1.48 [0.88 to 2.08] Maximum diameter −8.0 [−8.8 to −7.2] −5.9 [−6.9 to −4.8] 2.25 [1.37 to 3.14] Product of min*max diameter −50.5 [−59.5 to −41.5] −50.2 [−65.9 to −34.6] 5.95 [1.35 to 10.56]
(b) Parameter Complete disappearance
𝑛
(%)Fisher’s exact test Heparan sulfate GAGPS Pain at rest 46 (95.8) 45 (93.8) NS Pain on movement 30 (62.5) 11 (22.9) <0.0001 Functional disability 30 (62.5) 15 (31.3) 0.0015 Oedema 43 (89.6) 28 (58.3) <0.0001 Colour of the lesion 38 (79.2) 15 (31.3) <0.0001