Results of a randomised controlled trial between an ORC collagen hemostatic agent and a carrier-bound fibrin sealant

Pallaske, F.; Seebauer, Christian; Kaltofen, D.; Dziomber, S.; Rudolph, Heike; Schwanebeck, Uta; Grählert, Xina; Schulze, G. E. R.; Pallaske, A.; Boese-Landgraf, J.; Schlömann, Michael; Daeschlein, G.

doi:10.1016/j.jviscsurg.2020.06.015

Cited by 1 publication

(2 citation statements)

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“…Superficial surgical site infection, temporary hypocalcemia, T A B L E 5 Adverse events up to final follow-up visit (safety population) hypoparathyroidism, and so forth, were reported in some thyroid surgery. [31][32][33] Mild AEs are also commonly reported in soft tissue surgery, including procedural pain, nausea, constipation, itching, muscle spasm, insomnia, fever, vomiting and other phenomena. 1 It is reasonable that the incidence of SAEs may be unrelated to the treatment.…”

Section: Discussionmentioning

confidence: 99%

“…The majority of AEs reported in both groups in our study were either mild or moderate in severity and similar to those communicated in clinical trials using local hemostats on similar surgical procedures. Superficial surgical site infection, temporary hypocalcemia, hypoparathyroidism, and so forth, were reported in some thyroid surgery 31–33 . Mild AEs are also commonly reported in soft tissue surgery, including procedural pain, nausea, constipation, itching, muscle spasm, insomnia, fever, vomiting and other phenomena 1 .…”

Section: Discussionmentioning

confidence: 99%

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Prospective, randomized, controlled, noninferiority clinical trial to evaluate the safety and efficacy of absorbable macroporous polysaccharide composites as adjunct to hemostasis during open surgery

et al. 2022

Journal of Cardiac Surgery

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Background: To address intraoperative bleeding in cardiac surgery, reducing blood transfusion requirements, is mandatory to achieve effective hemostasis. Hemostatic agents may limit localized persistent bleeding. The introduction of carboxymethylchitosan component into the hemostatic agent and the application of the radiation crosslinking technique maintain its capacity for achieving intraoperative hemostasis, thus increasing the clinical utility.Methods: A prospective, noninferiority and randomized controlled clinical trial to compare the safety and efficacy of absorbable macroporous polysaccharide composites (AMPC, treatment group) with compound microporous polysaccharide hemostatic powder (CMPHP, control group) (2:1 ratio) as adjuncts to hemostasis in open surgery. The main indication was used for hemostasis in various traumatic hemorrhage areas, including cardiothoracic, vascular, and general surgery. The primary endpoint was success rate of hemostasis within 300 s (at a 10% noninferiority margin). The secondary endpoint was hemostasis time. Both endpoints were assessed in the modified intention-to-treat (MITT) population.Safety parameters were assessed. This study is fully compliant with the CONSORT statement.Results: Randomized patients in AMPC and CMPHP groups were 168 and 84, respectively. In MITT population, the success rates of hemostasis within 300 s were 98.8% (163 of 165) in AMPC and 94.0% (78 of 83) in CMPHP (treatment difference 4.8% [95% CI -0.57% to 10.20%]). AMPC was thus noninferior to CMPHP.Hemostasis time (median [interquartile range]) with AMPC (87 [52.5, 180] s) was better than CMPHP (110 [54.5, 181] s). Changes in laboratory parameters over time and shifts to abnormal values were typical of surgeries and similar between two groups. No noticeable adverse effects associated with AMPC or CMPHP were observed.

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