PerClot for Use in Surgical Hemostasis: A Systemic Review and Meta-Analysis of Clinical Data

Objective: To demonstrate that PerClot’s efficacy is non-inferior to other hemostatic treatments and its safety is non-inferior to the standard of care (SoC) during surgery. Methods: Applying keywords and inclusion criteria, we queried electronic databases to conduct a systematic (e.g., Embase and Cochrane Library, etc.) and manual search (e.g., Google Scholar, etc.) for studies from 1 January 2008 (first CE marked date) to 30 March 2024. Results: Five published studies were included in this systematic review. From the included studies, 691 patients received either PerClot (n = 315) or other hemostatic agents/SoC/control (n = 376) in different surgical specialties. All five studies had comparable outcome measures, interventions, and control groups, allowing for the pooling of the study data. The primary outcomes were the achievement of hemostasis and time to hemostasis. At 7 min post-application, PerClot demonstrated non-inferior hemostasis performance as compared to Arista (absolute difference: −1.4%; 95% CI: −7.54, 4.74; p = 0.65). The time to achieve hemostasis was comparable between PerClot and other hemostatic agents (mean difference: 0.00 min; 95% CI: 0.00, 0.00; p = 1.00). No statistically significant difference in adverse event occurrence was observed between PerClot and other hemostatic agents/SoC groups (absolute difference: 0.02; 95% CI: −0.30, 0.35; p = 0.2691) and the absence of new unknown adverse events indicates the safety profile of PerClot. The results of all outcome measures are statistically insignificant. Conclusions: Our systematic review demonstrated that PerClot achieved comparable hemostasis with no new safety concerns and a statistically significant reduction in postoperative drainage volume, indicating its safety, efficacy, and performance as an alternative for hemostasis across multiple surgical specialties.