Microporous Polysaccharide Hemospheres Research Articles

Evaluating the safety and efficacy of a novel polysaccharide hemostatic system during surgery: A multicenter multispecialty prospective randomized controlled trial

BackgroundOperative blood loss is associated with postoperative morbidity and mortality in surgery. Hemostatic agents are used as adjuncts for hemostasis during surgery and help to prevent postoperative bleeding. We evaluated the safety and efficacy of an investigational polysaccharide hemostatic (PH) topical product compared to a U.S. Food and Drug Administration (FDA)-approved control in clinical use comprising microporous polysaccharide hemospheres (MPH) to achieve hemostasis of bleeding surfaces during surgery. Study designThis prospective multicenter trial enrolled patients undergoing open elective cardiac, general, or urologic surgery. Patients were stratified by bleeding severity and therapeutic area, then randomized 1:1 to receive PH or MPH. Bleeding assessments occurred intraoperatively using a novel bleeding assessment methodology. Primary endpoint was noninferiority as compared with control via effective hemostasis at 7 min. Patients were monitored and followed daily in the postoperative period until time of discharge and again at 6 weeks. Overall survival was assessed in oncology patients at 24 months. Safety of PH vs. MPH was determined by comparing relative incidence of adverse events. ResultsAcross 19 centers, 324 (161 PH, 163 MPH) patients were randomized (48 % general surgery, 27 % cardiac surgery, and 25 % urologic surgery). PH was noninferior to MPH and met the primary endpoint of hemostatic success at 7 min at a non-inferiority margin of 10 %. No significant differences were found in adverse event rates. Six deaths were reported within the 6-week follow-up period. No difference in overall survival was observed at 2 years (76 % PH vs. 74 % MPH, P = .66) for patients undergoing cancer operations. ConclusionAcross three therapeutic areas, PH was noninferior to MPH at all hemostasis assessment time points with no safety concerns. PH is an effective alternative to MPH for hemostasis during surgery.ClinicalTrials.gov Identifier: NCT02359994

Review of Evidence Supporting the Arista™ Absorbable Powder Hemostat.

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. 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)). 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. Published evidence supports the safe and effective use of MPH across a variety of surgical settings.

Comparison of blood loss between intra-articular microporous polysaccharide hemospheres powder and tranexamic acid following primary total knee arthroplasty

Total knee arthroplasty (TKA) is associated with substantial blood loss and tranexamic acid (TXA) effectively reduces postoperative bleeding. Although it is known that there is no difference between intravenous or intra-articular (IA) injection, the general interest is directed towards topical hemostatic agents regarding thromboembolic events in high-risk patients. This study aimed to compare the blood conservation effects of IA MPH powder and TXA in patients undergoing primary TKA. We retrospectively analyzed 103 patients who underwent primary TKA between June 2020 and December 2021. MPH powder was applied to the IA space before capsule closure (MPH group, n = 51). TXA (3 g) was injected via the drain after wound closure (TXA group, n = 52). All patients underwent drain clamping for three postoperative hours. The primary outcome was the drain output, and the secondary outcomes were the postoperative hemoglobin (Hb) levels during the hospitalization period and the perioperative blood transfusion rates. An independent Student’s t-test was used to determine differences between the two groups. The drain output in the first 24 h after surgery was significantly higher in the MPH group than in the TXA group. The postoperative Hb levels were significantly lower in the MPH group than in the TXA group. In patients with simultaneous bilateral TKA, there was a significant difference in the blood transfusion volumes and the rates between groups. It is considered that IA MPH powder cannot replace IA TXA because of an inferior efficacy in reducing blood loss and maintaining postoperative Hb levels in the early postoperative period after primary TKA. Moreover, in the case of simultaneous bilateral TKA, we do not recommend the use of IA MPH powder because it was notably less effective in the field of transfusion volume and rate.

Clinical effectiveness of microporous polysaccharide hemospheres in mastectomy for patients with breast cancer.

Microporous polysaccharide hemospheres (MPH) are hydrophilic particles administered to reduce the incidence of seroma after mastectomy, but their clinical effectiveness remains controversial. Because a previous randomized, controlled study in a small cohort could not demonstrate the effectiveness of MPH in breast surgery, we evaluated their effectiveness in surgery for breast cancer in a larger cohort. Medical records of 352 patients who underwent total mastectomy for breast cancer were retrospectively reviewed. Clinical data were compared between 126 patients who received MPH during surgery (MPH group) and 226 who did not (control group) according to surgical procedures. Patients were significantly older in the MPH group than in the control group because of selection bias, but other factors, such as body mass index and number of dissected lymph nodes, did not differ between groups. When analyzed by use of axillary manipulation, the drain placement period and drainage volume were significantly less in the MPH group than in the control group for patients with mastectomy and sentinel lymph node biopsy. Only drainage volume was significantly less in the MPH group for patients with mastectomy and axillary lymph node dissection. The frequency of total postoperative complications, such as seroma requiring puncture, did not differ between groups. Use of MPH may decrease the postoperative drainage volume and drain placement period in mastectomy for patients with breast cancer.

A Prospective Analysis of the Effects of a Powder-Type Hemostatic Agent on the Short-Term Outcomes after Liver Resection.

Background and Objectives: Postoperative bleeding is a significant cause of morbidity and mortality following liver resection. Therefore, it is crucial to minimize bleeding during liver resection and effectively manage it when it occurs. Arista® AH (Becton, Dickinson and Company, Franklin Lakes, NJ, USA) is a microporous polysaccharide hemosphere (MPH), a new plant-derived polysaccharide powder hemostat that can be applied to the entire surgical field. This study prospectively assessed the effectiveness of Arista for bleeding control when applied intraoperatively to the liver resection surface. Materials and Methods: Data were collected at Seoul National University Bundang Hospital for patients who underwent liver resection owing to malignant hepatocellular carcinoma or benign liver diseases. We compared the outcomes between 45 patients managed with Arista® AH (data were prospectively collected between September 2022 and May 2023) and 156 patients managed without the use of Arista® AH (data were retrospectively collected between January 2021 and December 2021). Results: There were no significant differences in patient characteristics between the two groups. The estimated blood loss (EBL) was significantly lower in the Arista® AH group compared with the control group (495.56 ± 672.7 mL vs. 691.9 ± 777.5 mL, p = 0.049). The mean postoperative hospital stay was significantly shorter in the Arista® AH group (5.93 ± 1.88 days vs. 6.94 ± 4.17 days, p = 0.024). The time to Jackson-Pratt drain removal was also significantly shorter in the Arista® AH group (4.64 ± 1.31 days vs. 5.30 ± 2.87 days, p = 0.030). The patient subgroup was divided into four categories based on the type of resection and the presence or absence of cirrhosis. Within the subgroup of major resections in non-cirrhotic patients, the Arista® AH group demonstrated significantly better outcomes compared to the control group, showed lower EBL, reduced need for blood transfusions, decreased volume of drain fluid collected within 48 h, earlier removal of drains, and shorter hospital stays. In contrast, for the other subgroups such as minor resection (both non-cirrhotic and cirrhotic) and major resection with cirrhosis, the differences between the Arista® AH and control groups in various parameters like EBL, blood transfusion rates, drain fluid volume, time to drain removal, and duration of hospital stay were not statistically significant. Conclusions: Arista® AH significantly improved intraoperative blood management and postoperative recovery in patients undergoing liver resection, particularly in non-cirrhotic patients who underwent major resection.

The Safety and Efficacy of Microporous Polysaccharide Hemospheres in Terms of the Complication Rates in Total Hip Arthroplasty for Femoral Neck Fractures: A Control-Matched Retrospective Cohort.

This study aimed to assess the safety and efficacy of microporous polysaccharide hemospheres (MPSHs) in managing blood loss and reducing the risk of postoperative haematoma and early periprosthetic joint infection (PJI) following total hip arthroplasty (THA) for femoral neck fracture (FNF), in the context of the existing treatment challenges. A control-matched retrospective analysis of 163 patients undergoing unilateral primary THA for displaced FNF between 2020 and 2023 was performed. The study group consisted of 74 patients who received MPSH administered intraoperatively. The control group consisted of 89 patients who received no topical haemostatics. One-to-one case-control matching between groups was performed. The primary outcome was a perioperative change in the haematologic values (haemoglobin, red blood cell count, haematocrit, platelet concentration) and transfusion rate. The secondary outcomes were the incidence of postoperative local haematoma formation, prolonged wound secretion, surgical site infection (SSI), and PJI within 3 months of surgery. Our analysis found no statistically significant differences in the haematologic parameters between the control and study cohorts. The changes in the haemoglobin concentration were not significant between the control group (3.18 ± 1.0 g/dL) and the treatment group (2.87 ± 1.15 g/dL) (p = 0.3). There were no significant differences (p = 0.24) in the haematocrit and red blood cell concentration (p = 0.15). The platelet levels did not significantly differ (p = 0.12) between the groups. Additionally, we found no significant discrepancy in the incidence of early PJI or blood transfusion rates between the groups. No adverse effects following MPSH use were recorded in the study group. Routine use of MPSH in THA for FNF management appears to be safe, with no observed adverse events related to Arista® use. Although there was a tendency towards reduced blood loss in the Arista® AH group, MPSH did not significantly impact bleeding complications, local haematoma formation, or subsequent PJI.

Real-World Data on the Effectiveness of Microporous Polysaccharide Hemospheres for Allowing Even Novice Surgeons to Perform Robot-Assisted Radical Prostatectomy Safely.

Radical prostatectomy can be performed more safely and with fewer com- plications since the advent of robot-assisted surgery. However, increased bleeding is a concern when robot-assisted radical prostatectomy includes lymph node dissection and nerve sparing. In real-world clinical practice, inexperienced surgeons sometimes perform robot-assisted radical prostatectomy. In this study, we investigated the effec- tiveness of microporous polysaccharide hemospheres as a local hemostatic agent in robot-assisted radical prostatectomy. We retrospectively evaluated 301 patients who underwent robot-assisted radical prostatectomy at our institution between December 2017 and November 2020. The patients were divided into 2 groups according to whether their surgery was per- formed after the introduction of microporous polysaccharide hemospheres as a local hemostatic agent (group A, n = 140) or before it (group B, n = 161: historical control). Preoperative androgen deprivation therapy was significantly more common in group A than in group B (23 vs. 11, P = .009). Furthermore, surgeons were significantly less experienced (P < .001) and the operation time was significantly longer (260 min- utes vs. 229 minutes; P < .001) in group A than in group B. There was no significant difference in any other patient background characteristics or in the surgical outcomes between the groups. The use of microporous polysaccharide hemospheres allowed even inex- perienced surgeons to perform robot-assisted radical prostatectomy without compro- mising surgical outcomes.

Utility of microporous polysaccharide hemospheres in severe hepatic trauma: Experimental study of hemostatic strength and ease of use

BackgroundAnimal studies confirm the utility of hemostatics against standard packing following severe liver injury. We investigated the efficacy and ease of use of novel microporous polysaccharide hemosphere (MPH) compounds (Perclot®, Baxter) in the treatment of severe hepatic hemorrhage in pig. MethodsPigs were randomized to one of two equal treatment groups: MPH compounds (n=12) and Standard Packing (n=12). All animals underwent standardized surgical devascularization of the suprahepatic veins (grade V) to induce severe hepatic injury. Measures relating to the hemostatic success were monitored at 12, 60, 120 minutes and 24 hours post injury. ResultsAnimals allocated to treatment with MPH compounds were associated with higher survival rates at 24 hours than those undergoing standard packing: 66.7% vs, 0%, respectively (p=0.001). At 120 minutes MPH compounds were also associated with reduced blood loss, median (IQR) 1.16 (0.60) vs. 10.19 (5.77) mL/Kg, respectively: p<0.001) as well as higher invasive mean arterial pressures (iMAP) median (IQR) 39.12 (11.29) vs. 25.75 (14.28) mmHg, respectively: p=0.14) and hemoglobin levels median (IQR) 5.45 (2.50) vs. 6.45 (1.73) g/dL, respectively p=0.127). Overall, the application of MPH compounds required nearly half the time of standard packing median (IQR) 32.92 (6.51) vs. 67.75 (14.66) sec, respectively: p<0.001). ConclusionsThe data suggests that the use of MPH works in a severe hemorrhage in the liver of pigs, improving many variables in comparison to standard packing, including survival, blood loss and speed of application and we conclude that this offers a potential alternative for the treatment of hepatic injury. Further work is needed to corroborate these findings.

43 (PB-043) Poster - Use of Arista™ AH Absorbable Hemostat in breast surgery – analysis of seroma volumes and duration of drainage

Background: Novel hemostatic agents such as Arista™ AH have been widely adopted in surgical procedures as the application is easy and direct to the bleeding site. Microporous polysaccharide hemospheres are a powder hemostat made from purified plant starch.

Evaluating the Safety and Efficacy of a Novel Polysaccharide Hemostatic System for Multidisciplinary Application: A Multicenter Prospective Randomized Controlled Trial

Introduction: Operative blood loss is associated with postoperative morbidity and mortality. Hemostatic agents are used as adjunctive methods for hemostasis during surgery and to prevent postoperative bleeding. We evaluated safety and efficacy of an investigational polysaccharide hemostatic (PH) device, compared with an FDA-approved control in clinical use comprising microporous polysaccharide hemospheres (MPH), to achieve hemostasis of bleeding surfaces during surgery. Methods: This prospective multicenter trial enrolled patients undergoing open elective cardiac, general, or urological operation. Patients were stratified by bleeding severity and therapeutic area, then randomized 1:1 to receive PH or MPH. Bleeding assessments occurred intraoperatively using a novel bleeding assessment methodology. Primary endpoint was non-inferiority as compared with control via effective hemostasis at 7 minutes. Patients were followed postoperatively, discharge, and 6-weeks. Survival was assessed in oncology patients at 24-months. Safety of PH vs MPH was determined by comparing relative incidence of adverse events. Results: Across 19 centers, 324 (161 PH, 163 MPH) patients were randomized; approximately half underwent general surgery, while 25% each underwent cardiac and urologic surgery. PH met the primary endpoint of hemostatic success at 7-minutes demonstrating efficacy of PH was non-inferior to MPH. No significant differences were found in adverse event rates or supplementary safety measures. Six deaths were reported through 6-week follow-up. There was no difference in survival at 2 years (76% (PH) vs 74% (MPH), p = 0.66) for patients undergoing cancer operation. Conclusion: Across 3 therapeutic areas, PH was noninferior to MPH at all hemostasis assessment time points. No safety concerns were identified.

Effect of microporous polysaccharide hemospheres on anterolateral thigh free flap donor site complications.

BackgroundPostoperative seroma is the most common donor site complication following anterolateral thigh (ALT) free flap harvest for head and neck reconstruction. The utility of novel microporous polysaccharide hemospheres (MPH) has not been studied as a hemostatic agent in this setting.MethodsProspective, single‐blind, randomized controlled trial of patients undergoing fasciocutaneous ALT harvest for head and neck reconstruction at a tertiary academic medical center between April 2018 and February 2020. The intervention (MPH) group received 3 g of topical MPH to the ALT donor site prior to closure whereas the control group did not receive application of MPH. Outcomes included total drain output (ml), drain output during postoperative days (POD) 1–3 alone, drain duration (days), and incidence of donor site hematoma, seroma, or infection.ResultsTwenty‐nine patients were randomized to the MPH group and 26 to the control group. For MPH and control groups, mean total drain output was 284.7 ± 153.0 ml versus 317.9 ± 177.6 ml (p = .527), mean POD 1–3 drain output alone was 169.3 ± 88.8 ml versus 157.9 ± 78.7 ml (p = .749), and drain duration was 5.9 ± 1.5 days versus 6.5 ± 1.6 days (p = .144), respectively. There was no significant difference in seroma (p = .733), hematoma (p = .492), or infection (p = 1.000). Drain output was not significantly influenced by gender, age, body weight, or smoking habits.ConclusionMPH administration to ALT free flap donor sites did not significantly improve drain output, hematoma formation, or seroma formation.Level of Evidence 2

Absorbable Hemostatic Particles to Reduce the Damage on the Follicular Reserve After Ovarian Endometriomas Stripping

Objective: to reduce the surgical damage to the ovarian reserve, after stripping of ovarian endometrioma, of the necrotic type given by the electrohaemostasis or ischemic type given by the suture. Design: perform haemostasis on ovarian parenchyma with topical haemostatic agents. Materials and methods: we used Arista AH which is a powder made up of microporous polysaccharide hemospheres that act by osmotic action and accelerate the natural coagulation process. We used Arista AH in 27 women with mono- or bilateral ovarian endometriosis. Results: in all treated cases we obtained a rapid and optimal haemostasis. There were no post-surgical complications related to haemostatic defects. Three months after the surgery, we checked the Antral Follicle Count (AFC) with a trans-vaginal ultrasound probe. AFC in 24 women with full follow-up gave the following results: unilateral endometrioma – AFC between 5 and 8 (MV: 6.3), bilateral endometriomas – the AFC between 5 and 7 (MV: 5.8). Conclusions: The use of Arista AH powder allows highly effective hemostasis and is easy to use, fully respecting the residual ovarian parenchyma after stripping.

O28 APPLICATION OF MICROPOROUS POLYSACCHARIDE HEMOSPHERES DURING TRANSVERSUS ABDOMINAL RELEASE TO REDUCE SEROMAS AND HEMATOMAS

Abstract Aim Wound complications, like seromas and hematomas, occur in 23% after transversus abdominis release (TAR). Hemostat agents like fibrin glue have potential to reduce this rate, by vessel sealing and tissue bonding. But these are expensive. A topical hemostatic, like microporous polysaccharide hemospheres (MPH), is much cheaper, but its potential to reduce seromas and hematomas has never been analyzed in ventral hernia surgery. Material and Methods After the first 25 consecutive TAR patients (Control group, 2016-2018), MPH was introduced as an adjunct in a consecutive group of 25 TAR patients (Intervention group, 2019-2020). MPH was sprinkled in the TAR planes and subcutaneous tissue. Groups were compared. Results Pre-operative base-line characteristics and the overall complexity of the hernia patients and operations did not differ between the two groups. Postoperatively, the overall rate of surgical site occurrences (SSO) differed (CG:60%;IG:32%), but not significantly. Seromas (CG:5%;IG: 3%) and hematomas (CG:28%;IG:8%) did not differ significantly between the two groups. Medical complications (CG:13%;IG:10%) and two-year recurrence rate (CG:12%;IG:16%) also did not differ. Conclusions This study did not demonstrate a clear effect of MPH on the incidence of SSO, seromas or hematomas after a transversus abdominis release, despite the high incidence of wound complications in the first group of TAR patients (presumably, reflecting the learning curve of TAR). The fact that MPH does not glue tissue layers and minimize dead space, may be causative. MPH is not advised as an adjunct to reduce SSO.

PE08 - The effect of microporous polysaccharide hemospheres on patient outcomes following robot-assisted radical prostatectomy

PE08 - The effect of microporous polysaccharide hemospheres on patient outcomes following robot-assisted radical prostatectomy

Utility of Microporous Polysaccharide Hemosphere on Anterolateral Thigh Free Flap Donor Site Complications.

Background: Anterolateral thigh (ALT) microvascular free tissue transfer is an integral part of head and neck reconstructive surgery, but it can be complicated by postoperative donor site fluid collections. Objective: To measure the rate of hematoma and seroma formation in the ALT donor site in those treated with microporous polysaccharide hemosphere (MPH) and those without. Methods: This was a retrospective cohort study examining patients undergoing ALT free tissue transfer for head and neck reconstruction at a single academic center between 2014 and 2017. Primary outcomes were interventional hematomas and seromas and drain duration. Results: In total, 118 patients underwent ALT free flap reconstruction for head and neck defects. Of these, 57 patients received MPH at the donor site and 61 did not. Eleven patients had a clinically significant seroma in the non-MPH group compared with three in the MPH group (p = 0.045). Drain duration for the MPH group compared with that for the non-MPH group was 6.9 versus 8.2 days (p = 0.020), and drains were removed when output was <60 mL over 24 h. Conclusion: This study supports the use of MPH in ALT free flap donor sites for reduction of clinically significant postoperative seromas. Further investigation with larger prospective randomized clinical trials is warranted.

MP15-04 THE EFFECT OF MICROPOROUS POLYSACCHARIDE HEMOSPHERES ON PATIENT OUTCOMES FOLLOWING ROBOT-ASSISTED RADICAL PROSTATECTOMY

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy I (MP15)1 Sep 2021MP15-04 THE EFFECT OF MICROPOROUS POLYSACCHARIDE HEMOSPHERES ON PATIENT OUTCOMES FOLLOWING ROBOT-ASSISTED RADICAL PROSTATECTOMY Wissam Abou Chedid, Sarosh Janardanan, Liam Kavanagh, and Christopher Eden Wissam Abou ChedidWissam Abou Chedid More articles by this author , Sarosh JanardananSarosh Janardanan More articles by this author , Liam KavanaghLiam Kavanagh More articles by this author , and Christopher EdenChristopher Eden More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001996.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Controlling bleeding without disturbing the anatomy and function of the structures in the prostate bed remains a significant challenge during radical prostatectomy (RP). METHODS: The outcomes of 862 patients having robot-assisted RP (RARP) during a 5-year period were analyzed from a prospective database. The last 422 patients in the series had 5 g powdered microporous polysaccharide hemospheres (MPH) (Arista (TM), Becton Dickinson, USA) applied to the prostate bed at the end of surgery and the first 440 patients (control group) did not. Continence was defined as no pads and potency as the ability to have penetrative sex with or without PDE5 inhibitors in previously potent, non-diabetic men aged <70 years following bilateral intra- or inter-fascial neurovascular bundle (NVB) preservation. RESULTS: The control group contained higher-risk patients who had less nerve sparing done with a greater use of the Retzius-sparing approach (p=<0.01) but the two groups otherwise had similar demographic characteristics. Patients who received MPH had a trend towards a lower post-op. transfusion rate (p=0.12) and fewer total complications from post-operative bleeding (p=0.07) but these differences did not reach statistical significance. However, they had a significantly shorter operating time (p=<0.01), lower intra-operative blood loss, (p=<0.01), shorter hospital stay (p=<0.01), better continence and potency (p=<0.01) at 4 weeks, and better potency (p<0.01), trifecta (p=<0.01) and pentafecta (p=<0.01) rates at 1 year. CONCLUSIONS: The mechanism of the superior potency observed in the MPH group is unclear and may be due to less damage to the NVB following its preservation by clips and sutures, less local inflammation due to coating of the NVBs by a gel matrix, greater surgical experience or most likely a combination of these factors. The better early continence observed in the MPH group may be a consequence of better NVB preservation and its recognized beneficial effect on external urinary sphincter function. These results await further investigation within a randomized controlled trial . Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e264-e265 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Wissam Abou Chedid More articles by this author Sarosh Janardanan More articles by this author Liam Kavanagh More articles by this author Christopher Eden More articles by this author Expand All Advertisement Loading ...

Microporous polysaccharide hemospheres powder for hemostasis following nail surgery

The nail unit is a highly vascularized structure. Bleeding after nail surgery can be profuse, which may increase the risk of postoperative infection and delay wound healing. The efficacy of hemostatic agents, such as electrocautery, aluminum chloride, ferric subsulfate, kaolin-impregnated gauze, and hydrophilic polymers with potassium salts, varies and some can induce artifacts in histologic sections, potentially complicating future histologic examination. Brimonidine, an alpha-2 agonist, is effective for hemostasis following nail surgery, but is not easily accessible and must be avoided in patients with neurologic or cardiac diseases.

Evaluation of local hemostatic effect of microporous polysaccharide hemospheres products in thyroid surgery: a prospective randomized controlled study.

Bleeding is a rare and dangerous complication of thyroid surgery. One of the hemostatic agents used during surgery are microporous polysaccharide hemospheres (MPH) which are local hemostatic agents acquired from purified potato starch. The aim of this study was to evaluate the efficiency of two MPH, produced with different biotechniques, in decreasing hemorrhages and drainage following thyroidectomy. A statistical power analysis predicted that totally 20 patients per each group was needed within 95% confidential interval. Patients were randomized into 3 groups as control, Haemocer TM and Arista TM to be 20 patients in each group. Following bilateral total thyroidectomy, no additional procedures were performed in the first group, 5 g Haemocer was administered to the second group, 5 g Arista was administered to the third group into the operational field, and the operation was ended by placing a double-sided hemovac drain. At post-operative day one, drainage amount, calcium (Ca), phosphate (P) and parathyroid hormone (PTH) levels were noted. No significant difference was noted between the groups for age, gender, removed tissue weight and malignant pathology rates. Also, no significant difference was noted between post-operative drainages and Ca, P, PTH levels of groups either. Hoarseness or hematoma were not observed in any patient. MPHs are not proven in effectiveness in decreasing post-operative hemorrhages, which might be a key to avoiding unnecessary expenses.

Effect of topical microporous polysaccharide hemospheres on the duration and amount of fluid drainage following mastectomy: a prospective randomized clinical trial

BackgroundSeroma formation is the most common complication after mastectomy and places patients at risk of associated morbidities. Microporous polysaccharide hemospheres (MPH) consists of hydrophilic, plant based, polysaccharide particles and is currently used as an absorbable hemostatic agent. An animal model evaluating MPH and seroma formation after mastectomy with axillary lymph node dissection showed a significant decrease in seroma volume. Study aim was to evaluate topical MPH on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.MethodsProspective randomized single-blinded clinical trial of patients undergoing mastectomy for the treatment of breast cancer. MPH was applied to the surgical site in the study group and no application in the control group.ResultsFifty patients were enrolled; eight were excluded due to missing data. Forty-two patients were evaluated, control (n = 21) vs. MPH (n = 21). No difference was identified between the two groups regarding demographics, tumor stage, total drain days, total drain output, number of clinic visits, or complication rates. On a subset analysis, body mass index (BMI) greater than 30 was identified as an independent risk factor for high drain output. Post hoc analyses of MPH controlling for BMI also revealed no statistical difference.ConclusionsUnlike the data presented in an animal model, no difference was demonstrated in the duration and quantity of serosanguinous drainage related to the use of MPH in patients undergoing mastectomy for the treatment of breast cancer. BMI greater than 30 was identified as an independent risk factor for high drain output and this risk was not affected by MPH use. NCT03647930, retrospectively registered 08/2018.

Microporous polysaccharide hemosphere efficacy and safety in primary total knee arthroplasty

Absorbable hemostats such as microporous polysaccharide hemospheres (MPH) are used to manage hemostasis and prevent complications in total knee arthroplasty (TKA). We aimed to determine safety and effectiveness of MPH use in TKA. Records were reviewed for blood loss, hematomas, and infections. No differences existed regarding demographics, superficial infections (P = 0.933) or hematomas (P = 0.393). Positive correlation existed between hematoma and superficial infection (P = 0.009). Blood loss was greater in the treatment group (P = 0.014). MPH demonstrated inferior bleeding control and had no effect on complications. Our results suggest application of this agent may be unnecessary.