A Comparative Study of the Resorption and Immune Response for Two Starch-Based Hemostat Powders

Capella-Monsonís, Héctor; Shridhar, Arthi; Chirravuri, Bharadwaj; Figucia, Matthew; Learn, Greg D.; Greenawalt, Keith; Badylak, Stephen F.

doi:10.1016/j.jss.2022.09.022

Cited by 8 publications

(4 citation statements)

References 34 publications

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“…35 These results were recently confirmed and expanded upon in a comparison of Arista™ AH and PerClot ® . 38 In both an in vitro degradation assay and an in vivo preclinical model, Arista™ AH showed no crystallinity at any time point, no material detected by Day 3 and normal wound healing. In contrast, PerClot ® PHS showed slow resorption and the local persistence out to the Day 28 endpoint of crystalline degradation products that were associated with the onset of chronic inflammation and an early foreign body response.…”

Section: Starch Crystallinity As a Consideration In The Selection Of ...mentioning

confidence: 93%

Review of Evidence Supporting the Arista™ Absorbable Powder Hemostat

LyBarger

2024

MDER

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Background: Uncontrolled and diffuse bleeding is a dreaded event during open and laparoscopic surgery that may lead to postoperative complications, obstruction of the surgical field that reduces visualization, and prolonged operating times. Powder hemostats can be used to control bleeding and are easy to use, have a safe profile, and can achieve broad coverage area at a low cost. Methods: A strategic literature search of peer-reviewed, English language studies was conducted to capture evidence on the clinical efficacy and safety of a Microporous Polysaccharide Hemosphere (MPH) based Hemostat (Arista™ Absorbable Hemostat (Arista™ AH)). Results: Six preclinical studies were found which supported the use of MPH in various animal models of laparoscopic and open surgery, all of which demonstrated its safety and efficacy. Five single-arm and 11 comparative clinical studies similarly supported the efficacy and safety of MPH in various surgery types, including cardiac, renal, and dermatologic surgery. Conclusion: Published evidence supports the safe and effective use of MPH across a variety of surgical settings.

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Section: Starch Crystallinity As a Consideration In The Selection Of ...mentioning

confidence: 93%

Review of Evidence Supporting the Arista™ Absorbable Powder Hemostat

LyBarger

2024

MDER

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“…Intra-operative use of ARISTA induces rapid coagulation, reduces blood loss, and is completely degraded in 24-48 hours in vivo. 4 In vitro studies demonstrate that ARISTA promoted less of a proinflammatory response and was mostly degraded after 12 hours and completely after 3 days compared to other plant starch haemostatic agents such as STARSIL, thereby reducing the risk of foreign body reaction as well. 4,5 Despite this, there has been little investigation into the use of ARISTA in breast cancer surgery and seroma formation.…”

Section: Introductionmentioning

confidence: 99%

“…Microporous polysaccharide haemostatic agent based on plant starch (ARISTA) has been proposed to reduce seroma formation, haematoma, and infection in surgical wounds. 4 It has been in use in the United States of America since 2006, but remains a relatively new product in Australia, with approval for use by therapeutic goods administration being granted in 2016. ARISTA is an absorbable haemostatic agent derived from purified plantbased starch.…”

Section: Introductionmentioning

confidence: 99%

Impact of microporous polysaccharide haemostatic agent on patients undergoing mastectomy or axillary dissection on seroma formation and timing of drain removal

Mahmood,

Brodaric,

Srinivasan

et al. 2024

Int Surg J

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Background: Seroma formation is a known complication following mastectomy and axillary lymph node dissection (ALND) leading to morbidity and financial implications for patients. ARISTATM AH has been designed to prevent postoperative seromas formation in vitro. Methods: We performed a single institution, single surgeon retrospective study from January 2017 to December 2022 in patients undergoing mastectomy/axillary dissection to evaluate seroma formation rates and timing of drain removal. Results: A total of 72 cases were included in our retrospective review of electronic medical records. Of these, 40 patients underwent ipsilateral mastectomies with sentinel node biopsies, 8 patients underwent bilateral mastectomies, and 18 patients underwent axillary dissections without concurrent mastectomy. Our analysis showed a non-significant decrease in seroma formation when ARISTATM AH was used intra-operatively (10%) compared to standard care (24%), (p=0.14). The ARISTATM AH group had a statistically significantly longer mean drain removal time than the standard care group (12.9 vs 7.6 days, p=0.002). Conclusions: There was a trend towards lower seroma formation and a significantly longer requirement for drain placement after mastectomy in ARISTATM AH group. Further research including randomised controlled multi-centre study evaluating the benefit of topical haemostatic agents in reducing seroma formation in breast surgery is warranted.

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“…Animal studies are mainly carried out on 6–8 week old Sprague–Dawley rat models, in which the surgical site is performed on the abdominal area. Tests showed no signs of inflammation at any time after application of the powder [ 27 ]. The aim of this work was to evaluate the effectiveness and safety of the two devices in the surgical field by differentiating their application based on the pathology treated and the haemostasis mechanism exerted on it.…”

Section: Introductionmentioning

confidence: 99%

Synthetic Haemostatic Sealants: Effectiveness, Safety, and In Vivo Applications

Curcio,

Perri,

Piro

et al. 2024

Pharmaceuticals

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Rapid haemostasis during surgery is essential when one wants to reduce the duration of operations, reduce the need for transfusions, and above all when one wants to achieve better patient management. The use of haemostatic agents, sealants, and adhesives improves the haemostatic process by offering several advantages, especially in vascular surgery. These agents vary widely in their mechanism of action, composition, ease of application, adhesion to wet or dry tissue, immunogenicity, and cost. The most used are cyanoacrylate-based glues (Glubran 2) or polysaccharide hydrogel-microsphere powder (AristaTMAH). This work is based on a retrospective study carried out on a sample of patients with different vascular diseases (FAV, pseudoaneurysm, and PICC application) in which two different haemostatic sealants were used. The aim was to assess the safety, the advantages, and the ability of both sealants to activate the haemostatic process at the affected site, also in relation to their chemical-physical characteristics. The obtained results showed that the application of Glubran 2 and AristaTMAH as surgical wound closure systems is effective and safe, as the success achieved was ≥94% on anastomoses of FAV, 100% on stabilization of PICC catheters, and ≤95% on pseudoaneurysms.

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A Comparative Study of the Resorption and Immune Response for Two Starch-Based Hemostat Powders

Cited by 8 publications

References 34 publications

Review of Evidence Supporting the Arista™ Absorbable Powder Hemostat

Review of Evidence Supporting the Arista™ Absorbable Powder Hemostat

Impact of microporous polysaccharide haemostatic agent on patients undergoing mastectomy or axillary dissection on seroma formation and timing of drain removal

Synthetic Haemostatic Sealants: Effectiveness, Safety, and In Vivo Applications

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