PMID- 36071989
OWN - NLM
STAT- MEDLINE
DCOM- 20220909
LR  - 20220910
IS  - 1938-3797 (Electronic)
IS  - 1086-8089 (Print)
IS  - 1086-8089 (Linking)
VI  - 26
IP  - 3
DP  - 2022 Jul-Sep
TI  - Exploring Adverse Events and Utilization of Topical Hemostatic Agents in Surgery.
LID - 10.4293/JSLS.2022.00033 [doi]
LID - e2022.00033
AB  - 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.
CI  - (c) 2022 by SLS, Society of Laparoscopic & Robotic Surgeons.
FAU - O'Hanlan, Katherine A
AU  - O'Hanlan KA
AD  - Laparoscopic Institute for Gynecology and Oncology, Portola Valley, California.
FAU - Bassett, Paul
AU  - Bassett P
AD  - Meridian HealthComms, Plumley, United Kingdom.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - JSLS
JT  - JSLS : Journal of the Society of Laparoendoscopic Surgeons
JID - 100884618
RN  - 0 (Fibrin Tissue Adhesive)
RN  - 0 (Hemostatics)
RN  - 0 (Powders)
SB  - IM
MH  - Female
MH  - Fibrin Tissue Adhesive
MH  - *Hemostatics
MH  - Humans
MH  - Powders
MH  - Retrospective Studies
MH  - United States/epidemiology
MH  - United States Food and Drug Administration
PMC - PMC9439288
OTO - NOTNLM
OT  - Fibrin sealant system
OT  - Oxidized cellulose powder
OT  - Starch powder
OT  - Surgical hemostasis
EDAT- 2022/09/09 06:00
MHDA- 2022/09/11 06:00
PMCR- 2022/07/01
CRDT- 2022/09/08 02:19
PHST- 2022/09/08 02:19 [entrez]
PHST- 2022/09/09 06:00 [pubmed]
PHST- 2022/09/11 06:00 [medline]
PHST- 2022/07/01 00:00 [pmc-release]
AID - JSLS.2022.00033 [pii]
AID - 10.4293/JSLS.2022.00033 [doi]
PST - ppublish
SO  - JSLS. 2022 Jul-Sep;26(3):e2022.00033. doi: 10.4293/JSLS.2022.00033.