Efficacy and safety assessment of α-chymotrypsin injection in postoperative and post-traumatic edema: a prospective, open-label, multicenter observational registry study in Egypt

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Abstract

Background
Edema occurs because of trauma to tissues from an injury or a surgical procedure and is bothersome to both patients and treating physicians. The presence of edema is an initial component of the inflammatory response to tissue trauma. Chymotrypsin possesses potent anti-inflammatory properties that accelerate the reabsorption of inflammatory edemas as well as postoperative and post-traumatic hematomas and edemas. This study is a pioneer research to evaluate the efficacy and safety of α-chemotrypsin injection in postoperative and post-traumatic edema.
Patients and methods
A total of 529 patients with postoperative and postfracture edemas were recruited from three centers in Egypt (Orthopedic, Gynecology, and Surgery). Edema grades during visit 1 (V1) and visit 2 (V2) were evaluated and given scores from 1 to 4; their mean values were obtained and compared using the paired -test for the overall sample, for each center, and by nature of edema (postoperative and post-traumatic).
Results
Of the 529 patients, 523 (98.9%) cases improved, six (1.1%) cases did not change, and the condition of no patient worsened. The mean edema grade score in V1 in the overall sample was 2.75, which decreased to 1.53 in V2 (<0.001), with a percent change of −61%. There was a statistically significant difference in edema grade between V1 and V2. No adverse events or serious adverse events were reported during the study.
Conclusion
α-Chymotrypsin ampoules from Amoun are effective in lowering the edema grade and in managing patients with postoperative edema and postfracture edema as well.

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