Abstract
Hemostasis products, such as SURGICEL®, have been increasingly used across a wide variety of surgical procedures to mitigate bleeding-related risks and complications. This retrospective observational study described the utilization pattern of the SURGICEL® family of oxidized regenerated cellulose products (SURGICEL® ORIGINAL, SURGICEL® FIBRILLAR™, SURGICEL SNoW®) in a large, vertically integrated healthcare system, by utilizing electronic medical records (EMR) extracted from August 2013 through June 2015 at Henry Ford Health System (HFHS). Descriptive measurements were compared between SURGICEL® ORIGINAL and advanced SURGICEL® products (SURGICEL® FIBRILLAR™ and SURGICEL SNoW®) for pooled common surgical procedures. Among 1471 patients, 450 received SURGICEL® ORIGINAL, and 1021 received advanced SURGICEL® products. A significantly greater proportion of patients given advanced SURGICEL® products had comorbidities (91.0% vs 85.6%, p=.0024), prior bleeding conditions (49.9% vs 30.9%, p<.0001), and prior use of anticoagulants (27.7% vs 5.3%, p<.0001). Advanced SURGICEL® products were more likely to be used in coronary artery bypass grafting (13.7% vs 1.6%, p<.0001). Among a sub-set of 1420 patients with complete package size information (988 Advanced and 432 ORIGINAL), significantly fewer mean normalized units of Advanced SURGICEL® were used per patient case (3.9 vs 5.5, p<.0001). Despite Advanced SURGICEL® products being utilized in higher risk bleeding situations compared to cases where SURGICEL® ORIGINAL was utilized, fewer overall normalized units of Advanced SURGICEL® were required per patient case. Further research is needed to investigate the implications of topical hemostat use in continuous oozing bleeding situations on outcomes, hospital costs, and resources.
Highlights
All surgical procedures pose a risk of bleeding to the patient
Based on the superior hemostatic properties of advanced SURGICEL® products in comparison with SURGICEL® Original, we hypothesized that advanced SURGICEL® products would be more frequently used among patients with characteristics for higher bleeding risk, and fewer units of advanced SURGICEL® products would be used for each surgery compared to SURGICEL® Original
A total of 2605 patients were identified from the electronic medical records (EMR) system of Henry Ford Health System (HFHS) with keywords related to SURGICEL® products, of which 560 patients were excluded by applying each of the following exclusion criteria step by step: 1) received unidentifiable SURGICEL® product type (3 patients); 2) aged younger than 18 on index date (21 patients); 3) only received unrelated SURGICEL® products (489 patients); 4) received both SURGICEL® Original and Advanced SURGICEL® products (47 patients) (Figure 1)
Summary
All surgical procedures pose a risk of bleeding to the patient. Surgical site bleeding can cause complications of surgery and reoperation, and may lead to increased morbidity and mortality.[1,2] Uncontrolled bleeding is associated with higher rate of transfusions, which can negatively affect health outcomes and increase the cost of healthcare.[3,4,5] Certain conditions may exacerbate bleeding, such as use of anticoagulant drugs and comorbidities including obesity, arterial hypertension, diabetes mellitus and renal dysfunction.[6,7] Among these factors, bleeding history and use of anticoagulants have been used as part of assessment tools to predict bleeding risk prior to surgical procedures.[7]. Advanced SURGICEL® products include SURGICEL® FIBRILLARTM, a fibrous ORC that can be peeled to form layers and tufts[9], and SURGICEL SNoW®, an ORC with non-woven structure to increase surface contact with the bleeding site. These two advanced products were approved in 1996 and 2012, respectively. The patient characteristics related to bleeding risk and the units of product used for each surgery were compared between SURGICEL® Original and advanced SURGICEL® products for a diverse spectrum of pooled common surgical procedures
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