Gelatin-thrombin Matrix Research Articles

PMD80 - SYSTEMATIC REVISION AND META-ANALYSIS OF GELATIN-THROMBIN HEMOSTATIC MATRICES FOR BLEEDING CONTROL

Achieving hemostasis in surgical procedures is critical to prevent surgical bleeding progression, its associated complications and consequent additional hospital resource utilization. Gelatin-thrombin matrices (Surgiflo™ & Floseal™) are well-known products indicated as adjuncts to achieve hemostasis, with proven safety and efficacy in several types of surgeries. The objective of this study was to perform a systematic review and a meta-analysis to assess and compare safety, effectiveness and additional outcomes of Surgiflo™ & Floseal™ hemostatic matrices for bleeding control during surgical procedures. A systematic search of PubMed, Science Direct, Cochrane Library, Google Scholar and Medigraphic for published literature comparing both hemostatic matrices was conducted using the following key words: “Surgiflo”, “Floseal”, “gelatin thrombin matrix”, “meta-analysis”, “clinical trial” and “systematic review”. Inclusion criteria included RCTs and retrospective analyses comparing hemostatic matrices in procedures with high risk of surgical bleeding. For all relevant discrete outcomes (mayor & minor complications, blood transfusion, % patients achieving hemostasis ≤7 minutes), cumulative incidences and 95% CIs were estimated; for continuous outcomes (surgical time & length of stay), differences in means were evaluated. Results were pooled across studies by means of random- or fixed-effects models, depending on observed heterogeneity by means of the I2 statistic. All statistical analyses were performed with RevMan v.5.3. 193 studies were identified; only six studies met inclusion criteria (39,660 patients undergoing cranial & spinal procedures, laparoscopic nephrectomy and cardiac surgery). Forest plots were elaborated for all assessed outcomes; results demonstrate there are no statistically significant differences between evaluated hemostatic matrices in any of the considered outcomes. Substantial (>50%) and small (<25%) heterogeneity was observed. According to the results of this study, both hemostatic matrices are similar in terms of effectiveness, safety and other outcomes. Therefore, both technologies could be used indistinctly for any surgical procedure, with product choice having no impact on clinical outcomes.

Influence of Gelatin-Thrombin Matrix Tissue Sealant on Bacterial Colony Formation and Risk of Pelvic Infection.

Objective. Gelatin-thrombin matrix (GTM) tissue sealant use was previously identified as an independent predictor of pelvic infection following hysterectomies. We aim to elucidate contributing factors by assessing influence of GTM on bacterial colony formation and characterizing bacteria present at the vaginal cuff. Methods. Escherichia coli was incubated in phosphate-buffered saline (PBS) and pelvic washings with and without GTM to assess influence on colony formation. Pelvic washings of the vaginal cuff were collected from hysterectomies occurring from June through October 2015. In vitro techniques, 16S rRNA gene qPCR, and 16S amplicon sequencing were performed with washings to characterize bacteria at the vaginal cuff. Results. Mean bacterial colony formation in PBS was greater for E. coli incubated in the presence of GTM (1.48 × 107 CFU/mL) versus without (9.95 × 105 CFU/mL) following 20-hour incubation (p = 0.001). Out of 61 pelvic washings samples, 3 were culture positive (≥5000 CFU/mL) with Enterococcus faecalis. Conclusion. In vitro experiments support a facilitating role of GTM on colony formation of E. coli in PBS. However, given the negative results of surgical site washings following adequate disinfection, the role of GTM in promoting posthysterectomy pelvic infections may be limited. Analysis of pelvic washings revealed presence of E. faecalis, but results were inconclusive. Further studies are recommended.

A Gelatin-Thrombin Matrix Topical Hemostatic Agent (Floseal) in Combination With Harmonic Scalpel Is Effective in Patients Undergoing Total Thyroidectomy: A Prospective, Multicenter, Single-Blind, Randomized Controlled Trial.

Hemostasis during thyroidectomy is essential; however, the safest, most efficient, and most cost-effective way to achieve this is unclear. This randomized, multicenter, single-blind, prospective study evaluated the efficacy and safety of using different hemostatic approaches in patients undergoing total thyroidectomy. Patients aged ≥18 to 70 years were randomized to Floseal + a harmonic scalpel (HS), Floseal alone, HS alone, or standard total thyroidectomy. Primary endpoint was 24-hour drain output. Secondary endpoints included surgery duration and complications. Two hundred and six patients were randomized to Floseal + HS (n = 52), Floseal alone (n = 54), HS alone (n = 50), and standard total thyroidectomy (n = 50). The 24-hour drain output was lower in the Floseal + HS group compared with standard thyroidectomy. Floseal + HS also had a shorter surgery time (P < .0001) versus the other 3 treatments. Floseal + HS can be effective at reducing postsurgical drain output and provides a complementary hemostatic approach in patients undergoing total thyroidectomy.

Use of gelatin-thrombin matrix haemostatic sealant in neurosurgery: Anaesthetic implications and review of literature

AbstractThe topical haemostatic agents have been developed to be used as adjunctive measures to promote haemostasis. These include bone wax, absorbable gel sponges, microfibrillar collagen, oxidised regenerated cellulose, gelatin sponges with thrombin, gelatin-thrombin matrix sealant or fibrin sealants. Gelatin-thrombin matrix sealant is a mixture of a bovine-derived gelatin matrix and human-derived thrombin component that are mixed together at the time of use. This agent has been found to be more effective haemostat than thrombin-soaked gelatine sponges. The possible adverse effects of this can be transmission of diseases from human or bovine sources, allergic reactions, thromboembolism, disseminated intravascular coagulopathy (DIC), perilesional oedema, and compression of neural tissue. Although it is used routinely in the operating room, there is little literature available on the perioperative implications with use of intraoperative gelatin-thrombin matrix sealant. Here, we present clinical report of 20 neurosurgical patients where the sealant was used and literature in view of current evidence has been reviewed.

Efficacy of a Topical Gelatin-Thrombin Matrix Sealant in Reducing Postoperative Drainage Following Anterior Cervical Discectomy and Fusion

Study DesignRetrospective fusion level(s)-, age-, and gender-matched analysis.PurposeTo determine whether the application of a topical gelatin-thrombin matrix sealant (Floseal) at the end of anterior cervical discectomy and fusion (ACDF) can reduce the amount of postoperative hemorrhage.Overview of LiteratureThe effect of the matrix sealant in decreasing postoperative hemorrhage following ACDF has not been reported.MethodsMatrix sealant was (n=116, study group) or was not applied (n=58, control group) at the end of ACDF. Patients were selected by 1:2 matching criteria of fusion level(s), age, and gender. Seven parameters described below were compared between the two groups.ResultsThe total drain amount for the first 24 hours (8±9 versus 27±22 mL), total drain amount until the 8-hour drainage decreased to ≤10 mL (8±10 versus 33±26 mL), and the total drain amount until 6 AM on the first postoperative day (7±8 versus 24±20 mL) were significantly lower in the study group than the control group (all p<0.001). The time for the 8-hour drainage to decrease to ≤10 mL was significantly lower in the study group (10±5 versus 26±14 hours, p<0.001). The 8-hour drainage decreased to ≤10 mL on the operation day in most patients (88%) in the study group versus mostly on the first (48%) or second (33%) postoperative day in the control group (p<0.001). The total drain amount until 6 AM on the first postoperative day was 0 mL in 43% of patients in the study group and in 7% in the control group (p<0.001). No patient in either group required hematoma evacuation.ConclusionsApplication of the topical matrix sealant at the end of ACDF can significantly reduce the amount of postoperative hemorrhage.

Association Between Gelatin-Thrombin Matrix Use and Abscesses in Women Undergoing Pelvic Surgery

Association Between Gelatin-Thrombin Matrix Use and Abscesses in Women Undergoing Pelvic Surgery

Association between gelatin-thrombin matrix use and abscesses in women undergoing pelvic surgery.

To assess the association between the use of gelatin-thrombin matrix and the development of pelvic abscess during hysterectomy as well as factors associated with surgeons' use of this product. Data for patients undergoing hysterectomy for obstetric-gynecologic pathology were abstracted from databases at a tertiary hospital between 2009 and 2012. Open and minimally invasive hysterectomies were included and vaginal hysterectomies were excluded. Blood loss, surgery type, comorbidities, abscess formation, and use of gelatin-thrombin matrix were examined. Abscess was defined as a walled-off fluid collection (documented with computed tomography scan) with fever (greater than 38°C) or leukocytosis (greater than 11,000/microliter). Standard statistical models were used. Of the 413 patients identified, 213 (51%) underwent surgery for malignancy. Gelatin-thrombin matrix was used in 166 patients (40%). The overall rate of abscess was low (3%). In bivariate analyses, blood loss greater than 500 mL (odds ratio [OR] 3.9, 95% confidence interval [CI] 1.1-12.9, P=.021], ascites (OR 6.5, 95% CI 1.6-26.1, P=.023), drain placement (OR 4.5, 95% CI 1.3-15.1, P=.009), and gelatin-thrombin matrix use (OR 7.0, 95% CI 1.5-32.9, P=.009) were significantly associated with abscess formation. Multivariate logistic regression revealed that only gelatin-thrombin matrix use predicted the development of pelvic abscess (OR 7.0, 95% CI 1.5-32.9, P=.013). We found that gelatin-thrombin matrix use was associated with an increased risk of pelvic abscess. Although these products are important in the setting of bleeding, these data suggest that the liberal use of sealants is not without risk. III.

Total thyroidectomy with harmonic scalpel combined to gelatin-thrombin matrix hemostatic agent: Is it safe and effective? A single-center prospective study

IntroductionHemostasis during thyroidectomy is essential; however, the safest, most efficient and cost-effective way to achieve this is unclear. The aim of this study was to evaluate the outcome of total thyroidectomy (TT) performed with combination of harmonic scalpel (HS) and Floseal. MethodsPatients undergone TT were divided into two groups: HS + Floseal and traditional hemostasis groups. The primary endpoint was 24-h drain output and blood-loss requiring reintervention. Secondary endpoints included surgery duration, postsurgical complications and hypocalcemia rates. ResultsBetween September 2012 and January 2014, 165 patients were enrolled (100 to HS + Floseal, 65 to standard hemostasis); 80.5% female; mean age 42.3 years. The 24-h drain output was lower in the HS + Floseal group compared with standard TT. HS + Floseal also had a shorter mean surgery time (p < 0.0001) vs standard TT. No differences in post-surgical complications and in hypocalcemiarates between groups. Conclusioncombination of Floseal plus the HS is effective and safe for TT and it provides a complementary hemostatic approach.

Hemostatic gelatin-thrombin matrix is associated with pelvic abscesses in patients undergoing surgery for gynecologic cancer

Hemostatic gelatin-thrombin matrix is associated with pelvic abscesses in patients undergoing surgery for gynecologic cancer

Gelatin–Thrombin Matrix Hemostatic for Management of Severe Obstetric Hemorrhage

Gelatin–Thrombin Matrix Hemostatic for Management of Severe Obstetric Hemorrhage

Increased adhesion formation after gelatin-thrombin matrix application in a rat model.

To evaluate the effects of gelatin matrix and thrombin-based hemostatic sealant agents (gelatin-thrombin matrix) on postoperative adhesion formation in the rat uterine horn model. A total of fourteen female Wistar-Albino rats were used in our postoperative adhesion formation model. Both uterine horns were exposed by midline incision with sterile technique and each uterine horn was traumatized by bipolar electrocautery. Before closure of the abdomen, 0.9% NaCl solution was administered intraperitoneally in the control group and the gelatin-thrombin matrix was applied on the traumatized areas on the uterine horns of the rats in the study group. At day 21 after the first surgery, the intraperitoneal macroscopic adhesion scores and the extent of fibrosis, inflammation scores, inflammatory cell activities, inflammation types of adhesion tissues, and the level of free oxygen radicals [malondialdehyde (MDA)] and antioxidant enzyme activity [superoxide dismutase (SOD) and glutathione S-transferase (GST)] in the uterine horn tissue were measured. There was no statistically significant difference between the two groups in terms of macroscopic adhesion scores (p=0.064), MDA levels (p=0.121), and GST activity (p=0.360). However, there was statistically significant difference between the two groups in terms of the extent of fibrosis (p<0.001), inflammation score (p=0.001), inflammatory cell activity (p=0.002), and SOD activity (p<0.001). Gelatin-thrombin matrix was found to have increased the extent of fibrosis, inflammatory cell activity, and inflammation score, and reduced the activity of SOD, which acts to prevent cell damage.

Imaging Features of a Gelatin-Thrombin Matrix Hemostatic Agent in the Intracranial Surgical Bed: A Unique Space-Occupying Pseudomass

Absorbable gelatin-thrombin matrix is increasingly being used in neurosurgical procedures; unlike other hemostats, the stable matrix is left undisturbed and fills the surgical bed after achieving hemostasis. We investigated the immediate postoperative radiographic imaging appearance of the gelatin-thrombin matrix in intracranial operative beds. Thirty-one consecutive patients (18 men, 13 women; mean age, 59 years) with 34 surgical cavities, had 31 brain MRIs and 9 head CTs performed ≤ 48 hours postoperatively. They were retrospectively reviewed. Images were evaluated independently by 2 neuroradiologists blinded to the surgical techniques. Surgical beds were evaluated for the presence of the gelatin-thrombin matrix, which appeared as pseudoair material (Hounsfield units ≤ -100) on CT, had characteristic T2-hypointense speckles in a T2-hyperintense background, and demonstrated complete gradient-recalled echo hypointensity on MR imaging. To determine the diagnostic performance of imaging features for the detection of the gelatin-thrombin matrix, the Fisher exact test for the association between imaging features and the presence of the gelatin-thrombin matrix and κ analysis for interobserver agreement were performed. Hemostasis was achieved with standard methods in 12 surgical beds and with the gelatin-thrombin matrix in 22 beds. Interobserver agreement was substantial. The gelatin-thrombin matrix demonstrated pseudoair hypoattenuation (88% sensitivity, 100% specificity, 90% accuracy; P = .067, κ = 0.74) and distinctive T2-hypointense speckles in a background of T2-hyperintensity (81% sensitivity, 85% specificity, 82% accuracy; P = <.001, κ = 0.76). Combined characteristic T2 speckles and gradient-recalled echo hypointensity increased the specificity (81% sensitivity, 100% specificity, 88% accuracy; P = < .001). The unique appearance (pseudoair on CT, T2 speckles with gradient-recalled echo hypointensity) of the gelatin-thrombin matrix should not be mistaken for gossypiboma, pneumocephalus, and/or hematoma.

Prospective clinical trial of gelatin‐thrombin matrix as first line treatment of posterior epistaxis

To evaluate the effectiveness of gelatin-thrombin matrix for first line treatment of posterior epistaxis. Secondarily, we evaluated discomfort during treatment and the cost savings of treatment with gelatin-thrombin matrix compared to posterior packing, endoscopic, or endovascular treatment at our institution. Prospective pilot, nonblinded, noncontrolled registered clinical trial (NCT01098578). Twenty patients with posterior epistaxis were enrolled into this study. Gelatin-thrombin matrix was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion. Patients were discharged within 2 hours of being successfully treated. A visual analog scale (range 0-10) was used to assess treatment discomfort. Patients were evaluated in clinic 5 and 30 days after treatment to assess for intranasal complications and recurrent epistaxis. Gelatin-thrombin matrix successfully treated epistaxis in 80% of the patients. The procedure was associated with a mean discomfort of 3.6 (range 0-9.7). The institutional per case cost of treatment of patients with posterior epistaxis with gelatin-thrombin matrix is 80.3%, 87.4%, and 89.4% less than with endoscopic surgery, posterior packing, or embolization, respectively. There were no complications. This pilot study demonstrated that gelatin-thrombin matrix is a safe and both a clinically effective and cost-saving means of treating posterior epistaxis. In this study, its use is associated with a low level of discomfort. This treatment method may improve the quality of care for patients with posterior epistaxis.

Gelatin-Thrombin Matrix: A New and Simple Way to Manage Recurrent Epistaxis in Hematology Units

Introduction. In case of thrombopenia and/or thrombopathy, epistaxes are very difficult to manage. Case Series. Two patients, one with a thrombocytopenia, the other with a thrombopathy, were hospitalized because of repeated active epistaxes after failure of packing. Both patients were successfully treated with an application of Surgiflo without side effects and left the hospital without recurrence of epistaxis. Discussion. Being a subject of many studies dealing with epistaxis, Surgiflo is a simple treatment that seems to be very effective and without side effects to treat acute epistaxis in fragile patients with coagulation disorders. Prospective studies of tolerance and efficiency in such situations should be performed.

Gelatin-thrombin hemostatic matrix injection to salvage refractory post-renal graft biopsy bleed

Post-renal biopsy bleeding refractory to angioembolization usually requires graft nephrectomy as a life-saving measure. Gelatin-thrombin hemostatic matrix injection in the needle tract is a novel attempt to control bleeding in such cases and to salvage the allograft. We hereby describe two cases of post-graft biopsy bleed. Both these patients continued to bleed even after angioembolization. They were shifted to the operating room upon developing hypotension, having received multiple blood transfusions with the intention of performing graft nephrectomy to save their lives. However, bleeding was successfully controlled by using Gelatin-thrombin hemostatic matrix injection in the biopsy needle tract. Patients improved hemodynamically after the procedure. Graft function returned to normal in both the cases. At an average follow-up of 10.4 months, both the patients have shown stable graft functions.

Clip assisted use of gelatin–thrombin matrix sealant as a rescue procedure to treat a hidden arterial tear

Major intracranial arteries can be injured during tumor removal. Surgeons routinely manage this event by using either microvascular direct repair, by-pass of the wounded segment or the placement of a sutureless device. These procedures, however, are not always possible due to artery brittleness, deep operating field, vascular configuration, or restricted viewing field. In this particular case, we illustrate an example of innovative use of gelatin–thrombin matrix sealant used to repair a hidden tear of pericallosal–callosomarginal bifurcation. A 49-year-old man underwent resection of a recurrent left frontal glioma. During an attempt to remove a firmly attached portion of the tumor, a tear occured in the pericallosal–callosomarginal bifurcation. The wall defect was repaired with a temporary vascular clip placed on the pericallosal artery and gelatin–thrombin matrix sealant sprayed over the tear. An intraoperative indocyanine videoangiography showed patency of both the pericallosal and callosomarginal arteries. Gelatin–thrombin matrix sealant is useful to control bleeding from an artery when the viewing field is restricted. In some cases, however, blood outflow must first be reduced in order to allow clot formation.

Comparison of Purified Plant Polysaccharide (HemoStase) versus Gelatin-Thrombin Matrix (FloSeal) in Controlling Bleeding during Sinus Surgery: A Randomized Controlled Trial

Purified plant polysaccharide (HemoStase) is a plant-derived hemostatic agent that has not previously been used in sinus surgery. This study was conducted to evaluate the effectiveness of this novel agent in the control of nasal bleeding during endoscopic sinus surgery. The volume of bleeding during endoscopic sinus surgery was hypothesized to not be statistically significantly different between a control group (gelatin-thrombin matrix; FloSeal) and an experimental group (purified plant polysaccharide; HemoStase). Eighteen patients with a history of chronic rhinosinusitis in whom maximal medical therapy failed who underwent endoscopic sinus surgery were randomized into one of two groups (control FloSeal group or experimental HemoStase group). In the control group, sites in the nose that were actively bleeding during the operation were controlled with FloSeal. In the experimental group, sites in the nose that were actively bleeding during the operation were controlled with HemoStase. The main outcome measure was total operative blood loss. Blood loss was the sum of blood removed by suction during the surgery (recorded in milliliters) and blood on surgical sponges (weighed and converted to milliliters). Statistical analysis was performed with the t-test and the Mann-Whitney U test. The amounts of blood loss (mean +/- SEM) were not significantly different between the FloSeal (262 +/- 15 mL) and HemoStase (265 +/- 33 mL) groups (p = 0.93). The results of this study demonstrate the use of a novel product for the control of intraoperative bleeding during endoscopic sinus surgery.

Rapid diagnosis of sinonasal cancer in an anticoagulated patient: Outpatient clinical use of a gelatin-thrombin matrix (Floseal) for hemostasis following endonasal tumor biopsies

Introduction: The purpose of this case report is to describe the use of gelatin­thrombin matrix (Floseal) for hemostasis to control severe nasal bleeding following endonasal biopsies in an elderly patient receiving anticoagulant therapies. Case Report: An 81­year­old woman with advanced Alzheimer’s disease presented with rapid onset of midfrontal swelling, pain and orbital hypertelorism. Profuse bleeding occurred following tumor biopsies in the outpatient clinic which was controlled in less than five minutes with a single administration of Floseal. The pathologic diagnosis was diffuse large B­cell lymphoma and treatment was initiated within the week. There was no recurrence of bleeding following this single treatment. The use of Floseal safely and economically allowed for rapid diagnosis and treatment of this sinonasal cancer without the need to stop and restart anticoagulation therapy in an elderly patient with dementia. Conclusion: The outcome from the clinical management of this case suggests that this treatment approach may be a model for use in the rapid diagnosis of sinonasal pathology in the outpatient clinic even in the setting of anticoagulation.

Reducing blood loss at myomectomy with use of a gelatin-thrombin matrix hemostatic sealant

To evaluate the hemostatic efficacy and handling of gelatin-thrombin matrix in abdominal myomectomy. Prospective and randomized trial. University teaching hospital. Women (n = 50) with uterine fibroids with a uterine size equivalent to > or =16 weeks gestation. Gelatin-thrombin matrix (FloSeal Matrix; Baxter Healthcare Corp., Fremont, CA) was delivered to the site of the uterine bleeding during myomectomy. Patient age, parity, number of myomas, operative time, blood loss, transfusion, intraoperative and postoperative complications, and length of hospitalization were evaluated. The average blood loss during surgery was 80 +/- 25.5 mL for the FloSeal group and 625 +/- 120.5 mL for the control group. Intraoperative blood transfusion was necessary in five patients from the control group. Postoperative blood loss was 25 +/- 5 mL for the FloSeal group and 250 +/- 75 mL for the control group. Length of the postoperative hospital stay was 2.5 +/- 1.2 days for FloSeal group and 4.5 +/- 1.3 for the control group. No major immediate or delayed complications were observed in either group. Reductions in hemorrhage in FloSeal-treated women undergoing a myomectomy are encouraging, and provide evidence for the ability of gelatin-thrombin matrix to reduce blood loss when applied immediately and directly to bleeding uterine tissue.

A gelatin-thrombin matrix for hemostasis after endoscopic sinus surgery

Purpose Adequate hemostasis is necessary after endoscopic sinus surgery. This study evaluated the clinical performance of Surgiflo hemostatic matrix (Johnson&Johnson Wound Management, a division of Ethicon Inc, Somerville, NJ) with Thrombin-JMI (distributed by Jones Pharma Inc, Bristol, VA, a wholly owned subsidiary of King Pharmaceuticals, Bristol, TN) in achieving hemostasis in patients undergoing endoscopic sinus surgery. Surgiflo hemostatic matrix is a sterile, absorbable porcine gelatin intended to aid with hemostasis when applied to a bleeding surface. Materials and methods This multicenter, prospective, single-arm study evaluated the success in achieving hemostasis within 10 minutes of product application in patients undergoing elective primary or revision endoscopic sinus surgery for chronic sinusitis with a bleeding surface requiring hemostasis. Patient satisfaction and postoperative healing were also evaluated. Results Thirty patients were enrolled, including 17 males and 13 females (average age, 48.2 ± 15.1 years), with 54 operated sides. Twenty-nine patients achieved hemostasis within 10 minutes of product application (96.7% success rate; 1-sided 95% confidence interval, 85.1%–100%). The median total time to hemostasis including manual compression was 61 seconds. No complications, such as synechiae, adhesion, or infection, were reported. Conclusions Surgiflo hemostatic matrix with Thrombin-JMI was clinically effective in controlling bleeding in 96.7% of patients. Further randomized controlled trials are indicated.