Comparison of the efficacy of five standard topical hemostats: a study in porcine liver and spleen models of surgical bleeding

Paternò, Valerio Antonio; Bisin, Alessandro; Addis, Alessandro

doi:10.21203/rs.3.rs-32186/v2

Cited by 2 publications

(4 citation statements)

References 24 publications

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“…A recent comparative study in porcine liver and spleen bleeding models showed both powder and sponge gelatin-based mechanical hemostats to be effective for parenchymal surgical bleeding, but powder to be more suitable for mild diffuse bleeding. [27]…”

Section: Discussionmentioning

confidence: 99%

Safety and Hemostatic Effectiveness of SURGICEL® Powder (Oxidized Regenerated Cellulose) in Controlling Mild or Moderate Parenchymal or Soft-Tissue Intraoperative Bleeding

Al‐Attar

Jonge

Kocharian³

et al. 2022

Preprint

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Background. Topical hemostats reduce blood loss and optimize patient outcome and health care costs. The choice of agent depends on mode of action and surgical situation. This post-market clinical study evaluated the safety and effectiveness of Surgicel®-P, a powdered form of oxidized regenerated cellulose, designed to help control mild-to-moderate bleeding on broad or raw tissue surfaces.Methods. In a prospective, single-arm, multicenter trial, adult subjects with a target bleeding site (TBS) (mild-to-moderate bleeding for which conventional hemostatic methods were impractical or ineffective) were treated with Surgicel®-P. The primary endpoint was the proportion of subjects showing hemostasis at 5 minutes after application, without re-bleeding needing other hemostatic treatment. Secondary endpoints were these proportions at 3 and 10 minutes. The investigators’ ease-of-use evaluation of Surgicel®-P was recorded via questionnaire. Safety endpoints were the incidences of re-bleeding and thromboembolic events through day 30, and serious adverse events requiring surgical intervention through month 6 with a causal (including unlikely or at least possible) relationship to Surgicel®-P. Results. In 8 centers, 103 subjects were enrolled [median(range) age 64.0(33-88) years], of which 100 completed the study. Two deaths occurred, due to causes unrelated to Surgicel®-P. Surgeries were open (53.4%) or laparoscopic/thoracoscopic (46.6%), and mostly urological (37.9%) and abdominal (32.0%); TBSs included various tissue types, with mild (69.9%) or moderate (30.1%) bleeding over a median(range) surface area of 4(0.02–72.0) cm2. The 5-minute hemostatic success rate (primary endpoint) was 87.4%; the 3- and 10-minute rates (secondary endpoints) were 77.7% and 92.2%, respectively. Subgroup analyses showed 3-, 5- and 10-minute rates of 84.7%, 93.1%, 95.8% for mild, versus 61.3%, 74.2%, 83.9% for moderate bleeding, and 80.0%, 90.9%, 96.4% for open versus 75.0%, 83.3%, 87.5% for laparoscopic/thoracoscopic procedures. Within 10 minutes, initial manual compression (27.5%) was progressively abandoned, and additional Surgicel®-P was applied to 17.4% of TBSs. Investigators reverted to suture, cautery or other topical hemostats in 6.8% of procedures. No safety signals were identified. Investigators favorably evaluated the ease of use of Surgicel®-P device. Conclusions. This post-market clinical study supports the safety and efficacy of Surgicel®-P in controlling mild-to-moderate surgical bleeding in a broad range of surgical procedures.Clinical Trial Registration number. NCT03762200, 03/12/2018

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Section: Discussionmentioning

confidence: 99%

Safety and Hemostatic Effectiveness of SURGICEL® Powder (Oxidized Regenerated Cellulose) in Controlling Mild or Moderate Parenchymal or Soft-Tissue Intraoperative Bleeding

Al‐Attar

Jonge

Kocharian³

et al. 2022

Preprint

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“…A novel technique for port closure with the potential to reduce operating times and decrease the incidence of bleeding and herniation from the insertion of port-site trocars has been developed using a sterile absorbable gelatin sponge with strong hemostatic properties (Cutanplast® Plug) [26,27]. The technique has particular relevance to the obese population and is especially advantageous when access for the closure of port-site incisions by suturing is very difficult.…”

Section: Key Pointsmentioning

confidence: 99%

“…The company's products are manufactured and distributed according to ISO Classifications and European Union Directives. One of their products is Cutanplast®, a novel sterile resorbable gelatin with a powerful hemostatic effect [26,27].…”

Section: Trocar Port-site Closure Using Cutanplast Biodegradable Plugsmentioning

confidence: 99%

“…A range of Cutanplast products have been developed and have established roles as absorbable biomaterials with hemostatic and wound healing properties in applications such as nasal packing after endoscopic sinus procedures, dental surgery, anal surgery, and other gynecological, general, and orthopedic surgical procedures [27,41,42]. The gelatin sponge plug device used for port-site closure is biocompatible and non-toxic, hypoallergenic, has a neutral pH, and absorbs blood corresponding to approximately 50 times its own weight [27,[41][42][43]. It is rapidly hemostatic and completely absorbed over a period of 4-6 weeks [44] when left in situ, providing a safe and reliable method of port-site closure.…”

Section: Trocar Port-site Closure Using Cutanplast Biodegradable Plugsmentioning

confidence: 99%

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Safety and Efficacy of Trocar Port-Site Closure Using a Biological Plug Closure in Laparoscopic Bariatric Surgery: a Prospective Study

Andraos

2022

OBES SURG

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Purpose Port-site trocar closure is a challenging procedure in laparoscopic surgeries, especially in morbidly obese patients, and complications (herniation, bleeding, pain, and nerve trapping) have potentially severe consequences. This paper provides an overview of existing techniques of suturing and closure in intra-abdominal laparoscopic surgery, outlines the complications associated with port-site closure, and presents a novel technique designed to address those problems by using a sterile absorbable gelatin sponge with strong hemostatic properties (Cutanplast® Plug). Materials and Methods In this prospective study, 83 successive obese patients undergoing laparoscopic bariatric surgery (sleeve gastrectomy, sleeve plication, gastric bypass), using a standardized skin incision for trocar insertion, had port-site closure using the Cutanplast plug procedure (n = 42) or conventional suturing techniques (n = 41). Results The incidence of early complications was lower in the Cutanplast group; no patients had infections compared with 9.8% of Controls (p = 0.055) and no bleeding, ecchymosis, erythema, or redness occurred. Late complications during 2 years of follow-up were significantly lower in the Cutanplast group (0 vs. 7 hernias, p = 0.005). Most patients in the Cutanplast group required only 1–2 procedures (78.6% vs. 58.5%, p = 0.049), whereas 41.5% of controls required 3 procedures. In total, 82 trocars were used in the Cutanplast group versus 99 in controls. The single-step Cutanplast plug technique reduced operating times compared with two-step suturing techniques. Conclusion Closure of port-site trocar incisions using Cutanplast plug is fast, efficient, with potential to reduce operating times and decrease bleeding and herniation from port-site trocars insertion, particularly in obese patients. Graphical Abstract

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Comparison of the efficacy of five standard topical hemostats: a study in porcine liver and spleen models of surgical bleeding

Cited by 2 publications

References 24 publications

Safety and Hemostatic Effectiveness of SURGICEL® Powder (Oxidized Regenerated Cellulose) in Controlling Mild or Moderate Parenchymal or Soft-Tissue Intraoperative Bleeding

Safety and Hemostatic Effectiveness of SURGICEL® Powder (Oxidized Regenerated Cellulose) in Controlling Mild or Moderate Parenchymal or Soft-Tissue Intraoperative Bleeding

Safety and Efficacy of Trocar Port-Site Closure Using a Biological Plug Closure in Laparoscopic Bariatric Surgery: a Prospective Study

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