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Background: The transradial approach (TRA) for catheter interventions decreases vascular complications and bleeding versus transfemoral approach. Reducing time to hemostasis and preventing radial artery occlusion (RAO) following TRA are important and incompletely realized aspirations., Objectives: This first-in-human study sought to evaluate the efficacy of a novel, topically applied compound (hydrophobically modified polysaccharide-chitosan, hm-P) plus minimal required pneumatic compression, to achieve rapid radial arterial hemostasis in post-TRA procedures compared with de facto standards., Materials and Methods: About 50 adult patients undergoing 6 French diagnostic TRA procedures were prospectively enrolled. At procedure completion, a topical hm-P impregnated patch was placed over the dermotomy and TR Band (TRB) compression was applied to the access site. This patch was used as part of a novel rapid deflation protocol with a primary outcome of time to hemostasis. Photographic and vascular ultrasound evaluation of the radial artery was performed to evaluate the procedural site., Results: Time to hemostasis was 40.5 min (IQR: 38-50 min) with the majority of patients (n = 39, 78%) not requiring reinflation. Patients with bleeding requiring TRB reinflation were more likely to have low body weight and liver dysfunction, with absence of hypertension and LV dysfunction. The rate of RAO was 0% with predischarge radial artery patency documented in all patients using vascular ultrasound. One superficial hematoma was noted. No late bleeding events or cutaneous reactions were reported in the study follow-up., Conclusions: Topical application of hm-P in conjunction with pneumatic compression was safe and resulted in rapid and predictable hemostasis at the arterial puncture site., (© 2021 Wiley Periodicals LLC.)

Background: Hemostasis following transradial arterial access (TRA) is usually achieved by mechanical compression. This study investigated if use of a chitosan-based hemostatic pad (Clo-Sur Plus Radial™) combined with mechanical compression (TR Band®) could shorten hemostasis time after TRA, compared with a TR Band® alone., Methods: 40 patients undergoing cardiac catheterization and/or percutaneous coronary intervention were assigned into 4 cohorts post TRA: 10 patients received mechanical compression with a TR Band® alone for 120 min. The other 30 patients received compression with a Clo-Sur Plus Radial™ pad combined with a TR Band® for 60 min, 45 min, and 30 min, respectively (n = 10/per cohort). Times to hemostasis and access-site complications were recorded., Results: There were no differences in patient characteristics, mean dose of heparin, or mean activated clotting time value at the end of procedure among the four cohorts. Median time to hemostasis with the TR Band® alone was 120.5 min versus 60 min, 45 min and 30 min for the 60-min, 45-min, and 30-min Clo-Sur Plus Radial™ pad combined with the TR Band® cohorts, respectively. No radial artery occlusion, late rebleeding nor hematoma was noted in this series of patients., Conclusions: In this pilot trial, use of a Clo-Sur Plus Radial™ pad in combination with a TR band® significantly shortened hemostasis time, as compared to a TR band® alone, with no increased complications noted., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: A novel injectable expanding foam based on hydrophobically modified chitosan (HM-CS) was developed to improve hemostasis during surgeries. HM-CS is an amphiphilic derivative of the natural biopolymer chitosan (CS); HM-CS has been shown to improve the natural hemostatic characteristics of CS, but its internal safety has not been systematically evaluated. The goal of this study was to compare the long-term in vivo safety of HM-CS relative to a commonly used fibrin sealant (FS), TISSEEL (Baxter)., Methods: Sixty-four Sprague-Dawley rats (275-325 g obtained from Charles River Laboratories) were randomly assigned to control (n = 16) or experimental (n = 48) groups. Samples of the test materials (HM-CS [n = 16], CS [n = 16], and FS [n = 16]) applied to a nonlethal liver excision (0.4 ± 0.3 g of the medial lobe) in rats were left inside the abdomen to degrade. Animals were observed daily for signs of morbidity and mortality. Surviving animals were sacrificed at 1 and 6 wk; the explanted injury sites were microscopically assessed., Results: All animals (64/64) survived both the 1- and 6-wk time points without signs of morbidity. Histological examination showed a comparable pattern of degradation for the various test materials. FS remnants and significant adhesions to neighboring tissues were observed at 6 wk. Residual CS and HM-CS were observed at the 6 wk with fatty deposits at the site of injury. Minimal adhesions were observed for CS and HM-CS., Conclusions: The internal safety observed in the HM-CS test group after abdominal implantation indicates that injectable HM-CS expanding foam may be an appropriate internal use hemostatic candidate., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Patients on chronic hemodialysis often have acquired coagulopathy that can aggravate bleeding from puncture site after needle extraction. Chitosan-based pads have been reported to accelerate hemostasis even in the presence of coagulopathy. The aim of this study was to evaluate the hemostatic efficacy of the chitosan pads compared to gauze pads, applied for local hemostasis., Methods: A crossover study in a cohort of patients on hemodialysis with extended time to hemostasis after needle extraction. At the end of each dialysis, either gauze or chitosan pad was applied on both access points (arterial and venous). The type of pad was changed in the next dialysis all together 5 times in each patient (10 applications per patient for every pad)., Results: A total of 288 applications, 144 for each type of pad, were performed in 15 patients. The average time to hemostasis for the entire group was significantly shorter with the chitosan pads compared to the regular gauze pads ("arterial" point 3 vs. 18.5 min, p<0.001 "venous" access 2.8 vs. 13.2 min, p<0.001, respectively)., Conclusions: Chitosan pads significantly reduce time to hemostasis and should be considered for the treatment of accessible bleeds in patients with coagulopathy.

Uncontrolled hemorrhage leads to high death risk both in military and civilian trauma. Current hemostatic agents still have various limitations and side effects. In this study, natural diatom silica obtained from diatomite and diatom culture was purified and developed for hemorrhage control. To improve the biocompatibility and hemostatic performance of diatom silica, a series of chitosan-coated diatom (CS-diatom) was developed. The composition of CS-diatom prepared was optimized by in vitro hemocompatibility and blood coagulation evaluation for that prepared with 0.5%, 1%, 3%, and 5% chitosan. The results demonstrated that the CS-diatom prepared with 1% chitosan exhibited favorable biocompatibility (hemolysis ratio < 5%, no cytotoxicity to MEFs), great fluid absorbility (24.39 ± 1.53 times the weight of liquid), and desirable hemostasis effect (351 ± 14.73 s at 5 mg/mL, 248 ± 32.42s at 10 mg/mL). Further blood coagulation mechanism study indicated that CS-diatom could provide an ideal interface to induce erythrocyte absorption and aggregation, along with activating the intrinsic coagulation pathway and thus accelerated blood coagulation. Benefitting from the multiple hemostatic performances, CS-diatom showed the shortest clotting time (98.34 ± 26.54 s) and lowest blood loss (0.31 ± 0.11 g) in rat-tail amputation model compare to diatomite and diatom as well as gauze and commercial QuikClot zeolite. The results evidenced that the CS-diatom was a safe and effective hemostatic agent and provided a new understanding of nonsynthetic mesoporous materials for hemorrhage control.

Background: The purpose of this study was to evaluate the effectiveness and safety of endoscopically guided chitosan packing in controlling intractable epistaxis. A prospective case series was performed., Methods: This is a prospective clinical study conducted in a tertiary rhinology fellowship training hospital between January 2009 and November 2009. The study population consisted of patients with intractable epistaxis that failed to respond to traditional anterior-posterior nasal packing using either a 10-cm Pope PVA Merocel or a Rapid-Rhino. The bleeding site was identified using a nasal endoscope and controlled using a pack made of a ChitoFlex chitosan dressing wrapped around a polyvinyl acetal nasal sponge., Results: The intent-to-treat population consisted of 20 severe epistaxis subjects (8 men and 12 women) who continued to bleed despite traditional anterior-posterior nasal packing. The mean age was 67 years (±19 years). Sixteen subjects were on antiplatelets and/or anticoagulants. Eleven subjects (55%) presented with anterior epistaxis, and 7 subjects (35%) presented with posterior epistaxis. Chitosan nasal packing was performed on an outpatient basis and resulted in effective and immediate hemostasis in 19/20 subjects (95%). One subject had persistent bleeding after the first packing attempt and was successfully repacked within 30 minutes. Time to complete cessation of bleeding was 3.6 ± 2.2 minutes in the 19 subjects; the pack was removed after 48 hours, without any evidence of rebleeding or any serious side effects., Conclusion: Endoscopically guided chitosan packing is a safe, effective, and well-tolerated outpatient treatment for the management of intractable epistaxis.

Background: Postoperative bleeding and adhesion formation are the two most common complications after endoscopic sinus surgery (ESS). Continued bleeding risks airway compromise from the inhalation of blood clots and from the aspiration of blood-stained vomitus. Additionally, adhesion formation is the most common reason for patients requiring revision surgery. This study aimed to determine the efficacy of a novel chitosan/dextran (CD) gel on hemostasis and wound healing after ESS., Methods: A randomized controlled trial was performed involving 40 patients undergoing ESS for chronic rhinosinusitis. Immediately after surgery a baseline Boezaart Surgical Field Grading Scale was taken. Computer randomization was performed with one side receiving CD gel and the other side receiving no treatment (control). Boezaart bleeding scores were then calculated for each side every 2 minutes. Patient's endoscopic features of wound healing were assessed at 2, 6, and 12 weeks after surgery., Results: CD gel achieved rapid hemostasis with the mean time to hemostasis at 2 minutes (95% CI, 2-4 minutes) compared with 10 minutes (95% CI, > or =6 minutes) for the control (p < 0.001). There were significantly less adhesions at all time points with CD gel versus control: 2 versus 18 at 2 weeks (p < 0.001), 3 versus 16 at 6 weeks (p < 0.001), and 2 versus 12 at 3 months (p < 0.001). There was no significant difference between CD gel and control with respect to crusting, mucosal edema, infection, or granulation tissue formation., Conclusion: CD gel is rapidly hemostatic immediately after ESS and prevents adhesion formation, addressing two of the most common complications of sinus surgery.