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Background <p>Effective bleeding control is critical in trauma care to reduce morbidity and mortality. AriClot™ is a novel modified absorbable starch-based hemostatic powder (sodium carboxymethyl starch) that rapidly adsorbs fluid to concentrate clotting factors and form a gel barrier. This study aimed to compare the efficacy of AriClot™ hemostatic powder with standard cotton gauze in controlling bleeding in trauma patients to address a gap in the literature where RCTs on hemostatic powders for trauma are scarce.</p> Methods <p>A randomized controlled trial was conducted at Rajaee Emergency and Trauma Center, Shiraz, Iran, from June to September 2025. Fifty patients with traumatic wounds were randomized to receive either AriClot hemostatic powder (<i>n</i> = 27) or cotton gauze (<i>n</i> = 23). One patient in the control group was lost to follow-up, leaving 49 patients for analysis (27 AriClot, 22 cotton gauze). The primary outcome was bleeding control success rate at 3 and 6&#xa0;min, with secondary outcomes including rebleeding events and investigator opinions on treatment efficacy and early side effects. Success in bleeding control was defined as no visible bleeding from the wound, assessed by outcome assessors using visual inspection.</p> Results <p>AriClot demonstrated significantly higher success rates in bleeding control at both 3&#xa0;min (81.08% vs. 31.03%, <i>p</i> &lt; 0.0001) and 6&#xa0;min (89.19% vs. 51.72%, <i>p</i> = 0.0016) compared to cotton gauze. Rebleeding occurred less frequently in the AriClot group (21.62% vs. 48.27%, <i>p</i> = 0.0255). Investigator opinions favored AriClot, with a median score of 3.0 (IQR 2.0–3.0) versus 2.0 (IQR 1.0–3.0) for cotton gauze (<i>p</i> = 0.0051). Adverse events were minimal, with only a slight increase in self-limit burning sensation reported in the AriClot group (10.8% vs. 3.4%).</p> Conclusion <p>AriClot hemostatic powder is more effective than cotton gauze in controlling bleeding in trauma patients, with a favorable safety profile. These findings support its use as a frontline intervention in emergency trauma care, pending confirmation in larger, multicenter trials. Trial Registration: (IRCT20121117011491N3).</p>

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Efficacy of AriClot™ hemostatic powder versus standard pressure dressing for bleeding control in civilian penetrating trauma: A randomized controlled trial

  • 期刊论文

  • 发表日期：

    2026年3月9日

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  • Hossein Abdolrahimzadeh Fard,
  • Shahram Paydar,
  • Hossein Hosseini,
  • Hamid Reza Eftekharian,
  • Mahmood Naseri,
  • Seyed Mohammad Hashem hosseini,
  • Saeed Fazel,
  • Aboalfazl Hosaini,
  • Hamid Mohammadi

摘要

Background

Effective bleeding control is critical in trauma care to reduce morbidity and mortality. AriClot™ is a novel modified absorbable starch-based hemostatic powder (sodium carboxymethyl starch) that rapidly adsorbs fluid to concentrate clotting factors and form a gel barrier. This study aimed to compare the efficacy of AriClot™ hemostatic powder with standard cotton gauze in controlling bleeding in trauma patients to address a gap in the literature where RCTs on hemostatic powders for trauma are scarce.

Methods

A randomized controlled trial was conducted at Rajaee Emergency and Trauma Center, Shiraz, Iran, from June to September 2025. Fifty patients with traumatic wounds were randomized to receive either AriClot hemostatic powder (n = 27) or cotton gauze (n = 23). One patient in the control group was lost to follow-up, leaving 49 patients for analysis (27 AriClot, 22 cotton gauze). The primary outcome was bleeding control success rate at 3 and 6 min, with secondary outcomes including rebleeding events and investigator opinions on treatment efficacy and early side effects. Success in bleeding control was defined as no visible bleeding from the wound, assessed by outcome assessors using visual inspection.

Results

AriClot demonstrated significantly higher success rates in bleeding control at both 3 min (81.08% vs. 31.03%, p < 0.0001) and 6 min (89.19% vs. 51.72%, p = 0.0016) compared to cotton gauze. Rebleeding occurred less frequently in the AriClot group (21.62% vs. 48.27%, p = 0.0255). Investigator opinions favored AriClot, with a median score of 3.0 (IQR 2.0–3.0) versus 2.0 (IQR 1.0–3.0) for cotton gauze (p = 0.0051). Adverse events were minimal, with only a slight increase in self-limit burning sensation reported in the AriClot group (10.8% vs. 3.4%).

Conclusion

AriClot hemostatic powder is more effective than cotton gauze in controlling bleeding in trauma patients, with a favorable safety profile. These findings support its use as a frontline intervention in emergency trauma care, pending confirmation in larger, multicenter trials. Trial Registration: (IRCT20121117011491N3).