Katherine A O'Hanlan1, Paul Bassett2. 1. Laparoscopic Institute for Gynecology and Oncology, Portola Valley, California. 2. Meridian HealthComms, Plumley, United Kingdom.
Abstract
Background and Objectives: This retrospective study provides preliminary qualitative assessment of the adverse events (AEs), focusing on pelvic and abdominal AEs and patient outcomes reported for three hemostatic agents used in gynecologic surgery. Methods: Utilization rates for oxidized regenerated cellulose powder (ORC), polysaccharide powder (PSP), and fibrin sealant solution (FSS) were obtained from hospitals via the Premier Healthcare databases for all surgical procedures from January 1, 2018 to September 30, 2020. All reported cases were extracted from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for ORC and PSP and from the FDA Adverse Event Reporting System (FAERS) database for FSS. Distributions of AEs by anatomical site (MAUDE/FAERS) and surgical procedures by specialty (Premier) were evaluated for each product. Number of cases and number and types of AEs were compared to the total utilization for each product. Results: PSP was the most used product during the period analyzed (n = 126,509 uses), followed by FSS (n = 80,628 uses), and ORC (n = 41,583 uses). Distribution of surgical procedures by anatomical site varied significantly between hemostatic agents (p < 0.001). ORC was associated with more patient cases with AEs and numbers of reported AEs compared with PSP and FSS (p < 0.001). ORC was associated with higher number of infections than PSP (p < 0.001) and FSS (p < 0.001). Conclusion: These findings suggest that ORC use in abdominal and pelvic surgery may result in more postoperative complications compared with non-ORC hemostatic agents. Further prospective randomized studies are needed to compare efficacy and safety of these products.
Background and Objectives: This retrospective study provides preliminary qualitative assessment of the adverse events (AEs), focusing on pelvic and abdominal AEs and patient outcomes reported for three hemostatic agents used in gynecologic surgery. Methods: Utilization rates for oxidized regenerated cellulose powder (ORC), polysaccharide powder (PSP), and fibrin sealant solution (FSS) were obtained from hospitals via the Premier Healthcare databases for all surgical procedures from January 1, 2018 to September 30, 2020. All reported cases were extracted from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for ORC and PSP and from the FDA Adverse Event Reporting System (FAERS) database for FSS. Distributions of AEs by anatomical site (MAUDE/FAERS) and surgical procedures by specialty (Premier) were evaluated for each product. Number of cases and number and types of AEs were compared to the total utilization for each product. Results: PSP was the most used product during the period analyzed (n = 126,509 uses), followed by FSS (n = 80,628 uses), and ORC (n = 41,583 uses). Distribution of surgical procedures by anatomical site varied significantly between hemostatic agents (p < 0.001). ORC was associated with more patient cases with AEs and numbers of reported AEs compared with PSP and FSS (p < 0.001). ORC was associated with higher number of infections than PSP (p < 0.001) and FSS (p < 0.001). Conclusion: These findings suggest that ORC use in abdominal and pelvic surgery may result in more postoperative complications compared with non-ORC hemostatic agents. Further prospective randomized studies are needed to compare efficacy and safety of these products.
Authors: Kevin M Lewis; Qing Li; Drew S Jones; JoMichelle D Corrales; Hongyan Du; Philippe E Spiess; Emanuele Lo Menzo; Abe DeAnda Journal: Surgery Date: 2016-11-10 Impact factor: 3.982
Authors: Michael E Stokes; Xin Ye; Manan Shah; Katie Mercaldi; Matthew W Reynolds; Marcia F T Rupnow; Jeffrey Hammond Journal: BMC Health Serv Res Date: 2011-05-31 Impact factor: 2.655