Surgical Hemostat Research Articles

An Unusual Femoral Sheath Severing with Successful Recapture: A Case Report

This study presents a case of a successful severed femoral sheath recapture during transfemoral transcatheter aortic valve replacement (TAVR). During skin tunneling with a scalpel, the discontinuity of the femoral sheath occurred. Grasping of the distal sheath with the surgical hemostat was attempted unsuccessfully. A proximal part of the severed sheath was removed and Medtronic Sentrant introducer sheath (14 French) was then placed over the existing Confida wire which permanently remained in position, followed by the introduction of the Amplatz Left 2 (AL2) catheter which pushed the severed sheath in the ascending aorta over the Confida wire. The crucial maneuver was the entanglement of the severed sheath in the aortic non-coronary cusp which allowed for its entrapment by the AL2 catheter. This allowed for the coronary guidewire BMW Universal (0.014″) placement and a slow balloon retrieval (SeQuent NEO 2.5 × 25 mm2) of the severed sheath into the introducer sheath. The guidewire/balloon catheter was then exchanged for the support wire (0.035″) followed by the removal of the introducer sheath, AL2 catheter and the severed sheath. In conclusion, sheath severing is a complex accidental event during TAVR, which can be solved by intra-aortic recapture and retraction.

Evaluating the Safety and Toxicity of a Modified Dextran-based Biopolymer as a Hemostat

Background:As an effective alternative to conventional suture techniques, topical hemostatic agents are widely used to control bleeding and close wounds in surgeries.Objective:This study was conducted to evaluate the efficacy and safety of a novel hydrogel hemostat that is easy to use in an applicator under normal conditions according to ISO 10993.Methods:The safety of DexGel, a natural surgical hemostat containing mainly dextran that is an effective hydrogel in bleeding stop, was evaluated and compared to that of AristaTM. APTT test and cytotoxicity tests (i.e., MTT assay, Crystal violet assay, and qualitative estimation) were carried out for considering safety in skin sensitization in a guinea pig model.Results:This study has shown that DexGel does not cause any noticeable sensitization such as edema and erythema or observable toxicity for skin and does not disturb the coagulation process. In addition, cytotoxicity results approve its safety for cell survival.Conclusion:It can be concluded that the safety and efficacy of DexGel (5 g) are comparable or even better to that of AristaTM, which is a commercial and frequently used hemostat, and the lack of skin irritation and toxicity for DexGel alleviates initial safety concerns for products based on these polymers and oligomers.

In situ forming gelatin/hyaluronic acid hydrogel for tissue sealing and hemostasis.

Fibrin glue has been widely used as a surgical sealing and hemostatic agent. Its application is restricted due to poor tissue adhesion and low mechanical strength. To develop better tissue sealant and hemostatic agent, this study prepared the injectable hydrogels by chemically cross-linking gelatin (G) with or without hyaluronic acid (HA) in situ at a mild condition. The rheological analysis, Fourier transform infrared spectroscopy, swelling, proteolytic degradation, biocompatibility, tissue sealing, and hemostatic ability of the hydrogels were investigated. It was found that the chemical cross-linking rapidly formed in both self-crosslinking gelatin (sc-G) and gelatin/hyaluronate acid (G/HA) hydrogels. The hydrogels could be degraded by trypsin and had a desirable biocompatibility. The tissue sealing ability of the hydrogels was superior to fibrin glue. Furthermore, the G/HA hydrogel had similar hemostatic performance as fibrin glue, and was better than that of gelatin hydrogel. The results in the study indicated that the G/HA hydrogel could be used in clinic as a tissue sealant or surgical hemostat.

Comparative Efficacy of Advanced Surgical Hemostats in Canine Hepatotomy

In the present study Hemostatic effects of Surgicel Snow and Surgicel Fibrillar in 12 cases in dogs were observed. The dogs were divided into three groups via group A, B and C with four dogs in each group. All three groups were anesthetized by the combination of xylazine (1.1mg/kg) and ketamine (5.5mg/kg) administered intravenous. Group A received Surgical Gauze, Surgicel Snow was employed in Group B and Surgicel Fibrillar was used in Group C. Hemostasis time, Liver function test (LFT), Complete blood count (CBC), Temperature, Pulse rate and Respiratory rate (TPR), Ultrasonography were evaluated. Hemostasis time was significantly less in animals who had received a Surgicel Snow compared to Surgicel Fibrillar and Surgical Gauze. LFT values were significantly different among all three groups. CBC values also differ among all groups. In TPR there were no significant differences in all groups. All groups showed no changes during Ultrasonography of liver. Surgicel Snow is better hemostat than Surgicel Fibrillar with minimum blood loss and least effects on liver function.

Effect of Schwann and mesenchymal stem cells on experimentally induced sciatic nerve injury in rats

Objective Transplantation of bone marrow stromal cells (BMSCs) and Schwann cells (SCs) can facilitate axon regeneration in peripheral nerve injuries. The aim of this study was to explore the effect of transplantation of BMSCs and SCs on electrophysiological recording after injury of the sciatic nerve in the rat. Materials and methods In this study, 40 adult male albino rats (250-300 g) were used. BMSCs and SCs were cultured. Rats were divided randomly into four equal groups: group 1, control without nerve injury; group 2, nerve injury without cell transplantation; group 3, nerve injury with BMSCs transplantation; and group 4, nerve injury with SCs transplantation. Standardized crush injury of the sciatic nerve (axonotmesis) was performed by surgical hemostat at the first lock for 1 min; BMSCs and SCs were separately transplanted intralesionally. After 8 weeks, electrophysiological recordings were analyzed by one-way analysis of variance. Results Electrophysiological analysis showed a significant improvement in the cell transplantation groups compared with the injured group (P Conclusion BMSCs and SCs may potentially enable recovery after a standardized injury to the sciatic nerve in rats (axonotmesis). Electrophysiological evaluation confirms this improvement after transplantation of SCs and BMSCs, with no significant difference between them.

Use of a surgical hemostat modulates properties of clot associated with subchondral bone microdrilling in an ovine model for cartilage repair

Use of a surgical hemostat modulates properties of clot associated with subchondral bone microdrilling in an ovine model for cartilage repair

Comparison of regenerated and non-regenerated oxidized cellulose hemostatic agents

SummaryBackgroundOxidized cellulose is a well known and widely used surgical hemostat. It is available in many forms, but manufactured using either a nonregenerated or regenerated process.ObjectiveThis study compares the fiber structure, pH in solution, bactericidal effectiveness, and hemostatic effectiveness of an oxidized nonregenerated cellulose (ONRC; Traumastem®) and an oxidized regenerated cellulose (ORC; Surgicel® Original).MethodsIn vitro, fiber structures were compared using scanning electron microscopy, pH of phosphate buffer solution (PBS) and human plasma were measured after each cellulose was submerged, and bactericidal effect was measured by plating each cellulose with four bacteria. In vivo, time to hemostasis and hemostatic success were compared using a general surgery nonheparinized porcine liver abrasion model and a peripheral vascular surgery heparinized leporine femoral vessel bleeding model.ResultsUltrastructure of ONRC fiber is frayed, while ORC is smooth. ORC pH is statistically more acidic than ONRC in PBS, but equal in plasma. No difference in bactericidal effectiveness was observed. In vivo, ONRC provided superior time to hemostasis relative to ORC (211.2 vs 384.6 s, N = 60/group) in the general surgery model; and superior hemostatic success relative to ORC at 30 (60 vs. 15 %; OR: 13.5; 95 % CI: 3.72–49.1, N = 40/group), 60 (85 vs. 37.5 %; OR: 12.3; 95 % CI: 3.66–41.6), and 90 s (97.5 vs 70.0 %; OR: 21.1, 95 % CI: 2.28–195.9) in the peripheral vascular model.ConclusionONRC provides superior hemostasis and equivalent bactericidal effectiveness relative to ORC, which is likely due to its fiber structure than acidity.

Adhesion prevention in an intraperitoneal wound model: Performance of two resorbable hemostats in a controlled study in rabbits

Adhesions, particularly in the abdominal and pelvic cavities, represent a significant clinical problem. Among other complications, they are considered the most common cause of intestinal obstructions in the Western world. The purpose of this study was to evaluate two commercially available hemostats for their ability to prevent adhesion formation in an abdominal wound model. The hemostats, a microfibrillar collagen-based composite and microporous polysaccharide spheres were used in a rabbit abdominal model. In the model the cecum was abraded and a peritoneal defect was created on the abdominal sidewall. The test materials were applied over the defects. Clinical and histological results were compared with control (no application of any hemostat at the defect site) on postoperative day 14. The results showed a significant reduction in the incidence, extent and severity of adhesions for both surgical hemostat materials compared with control. The microfibrillar collagen-based composite showed a total absence of adhesions and a high level of reperitonealization. This preclinical study suggests that the use of surgical hemostats may help to reduce or eliminate adhesions and may promote reperitonealization.

Thrombin use in surgery: an evidence-based review of its clinical use

When surgical ligation of bleeding fails, or is not possible, surgeons rely on a number of hemostatic aids, including thrombin. This review discusses the history, pharmacology and clinical application of thrombin as a surgical hemostat. The initial thrombin was bovine in origin, but its use has been complicated by the formation of antibodies that cross-react with human coagulation factors. This has been associated with life-threatening bleeding and in some circumstances anaphylaxis and death. Human thrombin, isolated from pooled plasma of donors, was developed in an effort to minimize these risks, but its downsides are its limited availability and the potential for transmitting blood-borne pathogens. Recently a recombinant thrombin has been developed, and approved for use by the FDA. It has the advantage of being minimally antigenic and devoid of the risk of viral transmission. Thrombin is often used in conjunction with other hemostatic aids, including absorbable agents such as Gelfoam, and with fibrinogen in fibrin glues. The last part of this review will discuss these agents in detail, and review their clinical applications.

Exogenous bovine thrombin as a biomarker of exposure and outcome

Bovine thrombin has been used for more than 60 years as a surgical hemostat and sealant. Rare postsurgical events have been attributed to antibovine thrombin immunoglobulins cross-reacting with human homologs. In a literature review of 37 papers reporting safety outcomes in surgical patients, we extracted each paper for a quantitative measurement of bovine thrombin exposure and coagulopathic outcomes. We found that 59.5% of papers documented the commercial source of bovine thrombin and only 19% provided an estimate of exposure in units. Conventional tests for hypocoagulation were common (86%); however, only 9% of papers confirmed this inhibition as an isolated antibody. In addition, only 9% of papers cited a specific biomarker for thrombosis.

Clinical use of topical thrombin as a surgical hemostat

When surgical ligation of bleeding fails, or is not possible, surgeons rely on a number of hemostatic aids, including thrombin. This review discusses the history, pharmacology and clinical application of thrombin as a surgical hemostat. The initial thrombin was bovine in origin, but its use has been complicated by the formation of antibodies that cross react with human coagulation factors. This has been associated with life threatening bleeding and in some circumstances anaphylaxis and death. Human thrombin, isolated from pooled plasma of donors, has been developed in an effort to minimize these risks, but its downside is the potential of transmitting blood-borne pathogens and limited availability. Recently a recombinant thrombin has been developed and approved for use by the FDA. It has the advantage of being minimally antigenic and devoid of the risk if viral transmission. Thrombin is often used in conjunction with other hemostatic aids, including absorbable agents (like gelfoam, collagen, and cellulose), and with fibrinogen in fibrin glues. The last part of this review will discuss these agents in detail, and review their clinical applications.

A Novel Approach to the Treatment of Gunshot Injuries to the Sacrum

Two patients (a 17-year-old male and a 19-year-old female) sustained single gunshot wounds to the abdomen. Given the nature of their wounds and presumed peritoneal penetration they were taken urgently to the operating room for exploratory laparotomy. Both patients sustained multiple intra-abdominal injuries including gastric and small and large bowel perforations. Given the extensive nature of these injuries both patients required bowel resections. Upon further exploration they were both noted to have significant bleeding from the bony aspect of their sacrum. A surgical hemostat (CoStasis; Cohesion Technologies, Inc., Palo Alto, CA) (4.5-9.0 cm3) was directly applied to the injured area of the sacrum in both cases after standard surgical hemostatic techniques were unsuccessful. After application no further attempts of hemostatic control by standard methods were attempted. In both cases the sacral bleeding ceased without any further surgical intervention. Postoperatively neither patient rebled from the sacral injuries. Penetrating injuries to the sacrum can be life threatening and difficult to control with standard surgical hemostatic techniques. CoStasis, a new surgical hemostat, was effective in obtaining immediate and definitive hemostatic control. Future prospective trials on the use of CoStasis in trauma patients are warranted.

A novel method to control severe upper GI bleeding from metastatic cancer with a hemostatic sealant: The CoStasis surgical hemostat

Control of diffuse bleeding from primary and metastatic cancers in the GI tract is often difficult.1-3 Although surgery is an option, it is infrequently performed in patients with metastatic cancer who are often debilitated and have limited life expectancy. Angiography with embolization of feeding vessels can be used for brisk bleeding, but this may be difficult when multiple lesions are present. Endotherapy by injection, Nd:YAG laser photocoagulation, microwave coagulation, and electrocoagulation have been used with limited efficacy.

A novel collagen-based composite offers effective hemostasis for multiple surgical indications: Results of a randomized controlled trial

Background. Intraoperative bleeding is ubiquitous during open surgical procedures and uniformly effective hemostasis remains elusive. We conducted a randomized controlled trial to determine the effectiveness of a novel collagen-based composite (CoStasis Surgical Hemostat) compared with standard methods of hemostasis during general, hepatic, cardiac, and orthopedic operations. Methods. Hemostatic treatment was assigned randomly to 347 subjects; 318 subjects (167 CoStasis, 151 controls) underwent operation, received treatment, and provided hemostatic success data. CoStasis was applied to the bleeding site without manual pressure as a sprayable liquid composite of bovine microfibrillar collagen, bovine thrombin, and autologous plasma. Manual compression was used as the control hemostat. Hemostatic success was achieved if bleeding had ceased completely within 10 minutes (3 minutes for cardiac subjects). The time to controlled bleeding (ie, slight oozing) and time to complete hemostasis were recorded for all subjects. Results. Hemostatic success was achieved in more than 90% (153/167) of CoStasis subjects compared with 58% (88/151) of control subjects (P = .01). Superior hemostatic effectiveness with CoStasis was realized in every surgical specialty: general (77/79 vs 49/75, P = .01), hepatic (38/39 vs 20/29, P = .01), cardiac (28/37 vs 17/37, P = .02), and orthopedic (10/12 vs 2/10, P = .01). The duration of bleeding was also significantly shorter with CoStasis. The median time to controlled bleeding (42 seconds vs 150 seconds, P = .0001) and time to complete hemostasis (75 seconds vs 252 seconds, P = .0001) were both markedly longer with the control intervention. There were no serious adverse events related to the use of CoStasis. Conclusions. CoStasis is more effective at controlling and stopping diffuse intraoperative bleeding than standard methods of hemostasis in 4 distinct surgical indications representing a wide variety of operative interventions. (Surgery 2001;129:445-50.)

A Simple, Quantifiable, and Accurate Method for Applying a Noxious Mechanical Stimulus

A Simple, Quantifiable, and Accurate Method for Applying a Noxious Mechanical Stimulus

A simple, quantifiable, and accurate method for applying a noxious mechanical stimulus.

A simple, quantifiable, and accurate method for applying a noxious mechanical stimulus.