Gelatin-thrombin Matrix Research Articles

A case report of troubleshooting against bleeding from inferior vena cava injury.

We report a case of troubleshooting against bleeding from an inferior vena cava injury using a gelatin-thrombin matrix. A 58-year-old man underwent robot-assisted partial adrenalectomy for a right adrenal adenoma causing subclinical Cushing's syndrome. During the surgery, while dissecting between the adrenal gland and the inferior vena cava, bleeding occurred secondary to an inferior vena cava injury. Despite attempts at hemostasis, applying a human fibrinogen-thrombin patch and suturing were both difficult because of poor vision secondary to the bleeding. Hemostasis was ultimately achieved using a gelatin-thrombin matrix, which was accurately placed on the bleeding point using gauze. Open conversion was hence avoided, allowing the completion of the surgery as planned. Gelatin-thrombin matrix may be effective for managing relatively small inferior vena cava injuries.

Usefulness and Safety of Gelatin-Thrombin Matrix Sealants in Minimally Invasive Microscopic Discectomy.

Objective This study aimed to evaluate the usefulness and safety of gelatin-thrombin matrix sealants (GTMSs) in minimally invasive microscopic discectomy, a surgical procedure commonly used to treat lumbar disc herniation. Materials and Methods Out of 484 patients who underwent minimally invasive microscopic discectomy between April 2018 and December 2022, 35 patients with a history of surgery at the same level were excluded, resulting in a total of 449 patients included in the study. Among them, 316 patients were treated using GTMS, whereas 133 were treated using collagen-based absorbable local hemostatic agents. Patient characteristics, surgical duration, intraoperative blood loss, postoperative drainage volume, intraoperative dural injury, and incidence of postoperative epidural hematoma were analyzed and compared between the two groups. Results No significant differences in patient demographics were observed between the two groups, except for activated partial thromboplastin time and prothrombin time. Although there were no significant differences in the mean surgical time and intraoperative blood loss between the two groups, they tended to be shorter and less in the GTMS group (56.3 ± 20.2 vs. 58.2 ± 20.4 minutes [ p = 0.36] and 10.0 ± 15.4 vs. 11.8 ± 8.3 g [ p = 0.20]). The volume of postoperative drainage was significantly lower in the GTMS group than that in the comparison group (35.3 ± 21.8 vs. 49.5 ± 34.1 g [ p < 0.01]). There was a trend indicating a difference in the number of intraoperative dural injuries and the need for reoperation due to postoperative epidural hematoma (2 vs. 3 ± 20.4 minutes [ p = 0.21] and 1 vs. 2 [ p = 0.16]). Conclusion The use of a GTMS in minimally invasive microscopic discectomy appears to be beneficial in reducing postoperative drainage volume. It has also been shown that it may improve clinical outcomes such as intraoperative dural injury and postoperative epidural hematoma. Furthermore, further consideration of the medical economic impact is required.

Human gelatin thrombin matrix with rifampin for the treatment of prosthetic vascular graft infections

We aim to describe and report on a novel graft preservation technique using a human gelatin thrombin matrix with rifampin for the treatment of vascular graft infections. Eight patients with vascular graft infections were included, one with bilateral infections, for a total of nine cases from January 2016 through June 2021. All the patients underwent wound exploration and placement of human gelatin thrombin matrix with rifampin. No deaths or allergic reactions had been reported at the 30-day follow-up, with only one major amputation. The graft and limb salvage rates were 77.8% at the 1-year follow-up. The mean time to a major amputation was 122 days, and the mean time to graft excision was 30 days.

Efficacy of gelatin-thrombin matrix sealants for blood loss in single-level transforaminal lumbar interbody fusion.

Although gelatin-thrombin matrix sealants have been used successfully in other surgery types, their effect on reducing blood loss during single-level transforaminal lumbar interbody fusion is unclear. We thus examined the efficacy of gelatin-thrombin matrix sealants for reducing blood loss during such surgery. We analyzed 102 patients who underwent single-level transforaminal lumbar interbody fusion for lumbar degenerative disease. We compared body mass index, surgical time, intraoperative blood loss, postoperative blood loss, true total blood loss, hidden blood loss, the proportion of blood transfusion, blood pressure pre- and post-surgery (systolic and diastolic), and pre-and post-surgery laboratory data (hemoglobin, hematocrit, platelets, prothrombin time, activated partial thromboplastin time, and D-dimer) between patients in whom gelatin-thrombin matrix sealants were (GTMS group) or were not (control group) used during surgery. One-week postoperative epidural hematoma size was measured using magnetic resonance imaging. The GTMS and control groups included 54 (24 males and 30 females) and 48 patients (19 males and 29 females). Intraoperative, true total, and hidden blood loss; epidural hematoma size; and hospitalization duration were significantly lower in the GTMS than in the control group. Intraoperative blood loss correlated with surgical time (R = 0.523, P = .001), body mass index (R = 0.221, P = .036), and the amount of gelatin-thrombin matrix sealant used (r = -0.313, P = .002). In multivariate linear regression analysis using intraoperative blood loss as the dependent variable, surgical time (standardization coefficient 0.516, P = .001) and amount of gelatin-thrombin matrix sealant used (standardization coefficient -0.220, P = .032) were independently related factors. In our study, the GTMS group had significantly less intraoperative true total and hidden blood loss than did the control group. Thus, use of gelatin-thrombin matrix sealants reduce perioperative blood loss in transforaminal lumbar interbody fusion.

Real-World Effectiveness of Gelatin-Thrombin Matrix Sealant on Blood Loss in Adolescent Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion: An Interrupted Time Series Study.

Retrospective cohort study with interrupted time series analysis. To examine the clinical effectiveness of gelatin-thrombin matrix sealant (GTMS) on blood loss reduction after adolescent idiopathic scoliosis (AIS) surgery. The real-world effectiveness of GTMS on blood loss reduction in AIS surgery has not been determined. The medical records of patients receiving AIS surgery were retrospectively collected during a period before GTMS approval at our institution (January 22, 2010-January 21, 2015) as well as during a postintroduction period (January 22, 2015-January 22, 2020). The primary outcomes were intraoperative blood loss, drain output over 24 hours, and total blood loss (intraoperative blood loss + drain output over 24 h). Interrupted time series analysis using a segmented linear regression model was used to estimate the effect of GTMS on blood loss reduction. A total of 179 AIS patients [mean age (range): 15.4 (11-30) yr; 159 females and 20 males; 63 preintroduction patients and 116 postintroduction patients] were included. After its introduction, GTMS was used in 40% of cases. Interrupted time series analysis revealed changes of -340mL (95% CI: -649 to -31, P = 0.03) for intraoperative blood loss, -35mL (95% CI: -124 to 55, P = 0.44) for drain output over 24 hours, and -375mL (95% CI: -698 to -51, P = 0.02) for total blood loss. The availability of GTMS was significantly associated with reduced intraoperative and total blood loss in AIS surgery. GTMS use as needed is recommended to control intraoperative bleeding in the setting of AIS surgery. 3.

Safety and Efficacy of Gelatin-Thrombin Matrix Sealants (Floseal) for Hemostasis During Liver Resection (with video)

Background: The efficacy of gelatin-thrombin matrix sealants (Floseal®) for hemostasis has been well described in the field of cardiovascular surgery, but data supporting its safety and efficacy in liver surgery remains lacking.

EXTH-35. INCREASING THERAPEUTIC INDUCED NEURAL STEM CELL PERSISTENCE IN THE GLIOBLASTOMA TUMOR RESECTION CAVITY

Abstract BACKGROUND Induced neural stem cells (iNSCs) have emerged as a promising therapeutic platform for glioblastoma (GBM). iNSCs have the innate ability to home to tumor foci, making them ideal carriers for anti-tumor payloads. However, iNSC persist for only two weeks in the murine GBM tumor resection cavity. We hypothesized that by encapsulating iNSCs in a scaffold matrix, we could increase both the persistence of the cells the therapeutic durability. METHODS iNSCs expressing TRAIL were encapsulated in a gelatin-thrombin matrix; fibrinogen was used to polymerize the matrix. SEM was used to explore interactions between iNSCs and the scaffold matrix. To evaluate persistence, iNSCs encapsulated in the matrix were implanted into mock resection cavities of athymic nude mice and followed via BLI. To study the impacts of encapsulation on iNSC efficacy, athymic nude mice were implanted with U87 or GBM8 tumors. Tumors were then resected, and iNSCs encapsulated in the matrix were implanted; tumor volume was monitored via BLI. RESULTS SEM images showed homogeneous distribution of iNSCs throughout the matrix; iNSCs were completed encased in the fibrin clot component of the matrix and did not adhere to gelatin. In vivo, encapsulated iNSCs persisted for nearly 100 days whereas iNSCs directly injected into the brain parenchyma persisted &amp;lt; 20 days. Using mice bearing GBM8 tumors, animals treated with a high dose of therapeutic encapsulated iNSCs survived ~60 days longer than animals treated with non-therapeutic cells. A similar trend was observed in animals inoculated with U87 tumors. While not statistically significant, 25% of mice treated with iNSCs encapsulated in the gelatin-thrombin matrix survived longer than those treated with iNSCs encapsulated in a fibrin-only matrix, suggesting additional benefit due to the gelatin component. FUTURE DIRECTIONS: Prospective experiments will explore the impact of the scaffold on iNSC phenotype, including proliferation, differentiation, and migration markers.

The sole and combined effects of gelatin-thrombin matrix and freeze-dried bone allograft on early bone healing.

Gelatin-thrombin matrix (GTM) is a hemostatic agent with applications in maxillofacial surgery consisting of human-derived thrombin and bovine-derived gelatin matrix. The aim of this study was to evaluate the efficacy of GTM alone or with freeze-dried bone allograft (FDBA) in improving early bone healing. Forty-six adult male Sprague-Dawley rats were used. All animals were randomly assigned to a control group (n = 4) and three study groups (n = 14). Each group was divided into two subgroups for histomorphometric and histological analyses at weeks 1 and 4. The new bone formation, inflammation, fibrosis, necrosis, foreign body reaction, and bone healing scores were evaluated based on the histopathological findings. Multiple comparisons were performed using the Kruskal-Wallis test. Variables that were not normally distributed were evaluated using the Mann-Whitney U test. At 1 week, the GTM + FDBA group showed less bone formation (mean ± SD: 0.08 ± 0.03 mm2), compared with the study and control groups (FDBA: 0.15 ± 0.06 mm2; GTM: 0.13 ± 0.06 mm2). At 4 weeks, the GTM group (0.48 ± 0.1 mm2) showed more bone formation than the GTM + FDBA group (0.33 ± 0.17 mm2). Foreign body reactions were observed at weeks 1 and 4 in all GTM-containing groups. Within the limitations of this study, GTM group did not show a significant difference in bone formation compared with the control group. GTM did not inhibit bone healing at 1 and 4 weeks, and no significant difference was observed compared with the control groups. GTM was more effective for bone healing when administered without FDBA. GTM is considered safe when bone hemorrhage is encountered.

Effectiveness of a Gelatin-Thrombin Matrix Sealant (Floseal®) for Reducing Blood Loss During Microendoscopic Decompression Surgery for Lumbar Spinal Canal Stenosis: A Retrospective Cohort Study.

Retrospective cohort study. To investigate the effectiveness and safety of a gelatin-thrombin matrix sealant (GTMS) during microendoscopic laminectomy (MEL) for lumbar spinal canal stenosis (LSCS). This study included 158 LSCS cases on hemostasis-affecting medication who underwent MEL by a single surgeon between September 2016 and August 2020. Patients were divided into 2 groups depending on whether GTMS was used (37 cases, Group A) or not (121 cases, Group B). Perioperative data related to bleeding or postoperative spinal epidural hematoma (PSEH) was investigated. Clinical outcomes were evaluated using the Japanese Orthopedic Association (JOA) score for low back pain. The mean intraoperative blood loss per level was greater in Group A (26.0 ± 20.3 g) than in Group B (13.6 ± 9.0 g), whereas the postoperative drainage volume was smaller in Group A (79.1 ± 42.5 g) than in Group B (97.3 ± 55.6 g). No revision surgeries for PSEH were required in Group A, while 2 (1.7%) revisions were required in Group B (P = .957). The median JOA score improved significantly from the preoperative period to 1-year postoperatively in both Group A and B (total score, 16.0-23.5 and 17.0-25.0 points, respectively). The use of GTMS during MEL for LSCS may be associated with a reduction in postoperative drainage volume. The revision rate for PSEH was not affected significantly by the use of GTMS. Clinical outcomes (represented by the JOA score) were significantly improved after the surgery, regardless of GTMS use during MEL.

Dissolvable intranasal haemostatic agents for acute epistaxis: A systematic review and meta-analysis.

Nasal packing is the mainstay of epistaxis management; however, packs cause patient discomfort and can lead to hospital admission. Absorbable haemostats provide clotting factors or act as a substrate to stimulate clotting and represent a potential treatment alternative. A systematic review was performed to evaluate the efficacy of topical haemostats in the management of epistaxis. A systematic literature search of 7 databases was performed. Only eligible randomised controlled trials (RCTs) and observational studies were included. The primary outcome was short-term haemostatic success (<7days). Secondary outcomes included long-term haemostatic control (no rebleeding 7-30days), patient discomfort and adverse effects. Meta-analysis was performed where possible. Of 2249 records identified, 12 were included in the qualitative synthesis and 4 RCTs were included in meta-analysis. The following haemostats were reported: gelatin-thrombin matrix (n=8), aerosolised/gel tranexamic acid (n=1), cellulose agents (n=2) and fibrin sealants (n=1). Studies involving tranexamic acid on removable delivery devices (eg, pledgets) were excluded. There was heterogeneity in outcome measures and inclusion criteria (coagulopathies/anticoagulants were excluded in 3 RCTs and 2 observational studies). The short-term haemostatic success varied between studies (13.9% to 100%). No significant post-procedural complications were reported. The meta-analysis favoured absorbable haemostatic agent versus packing (risk ratio 1.20; 95% confidence interval 1.05 to 1.37; P=.007). The risk of bias across all studies was moderate to high. The evidence suggests haemostatic agents are effective at managing acute epistaxis when compared with nasal packing. More data are required before recommendations can be made regarding management in patients on anticoagulants.

Does prophylactic use of topical gelatin-thrombin matrix sealant affect postoperative drainage volume and hematoma formation following microendoscopic spine surgery? A randomized controlled trial

BACKGROUND CONTEXTMicroendoscopic spinal surgery has demonstrated efficacy and is increasingly utilized as a minimally invasive approach to neural decompression, but there is a theoretical concern that bleeding and postoperative epidural hematoma (PEH) may occur with increased frequency in a contained small surgical field. Hemostatic agents, such as topical gelatin-thrombin matrix sealant (TGTMS), are routinely used in spine surgery procedures, yet there has been no data on whether PEH is suppressed by these agents when administered in microendoscopic spine surgery. PURPOSEThe purpose of this study was to investigate the effect of TGTMS on bleeding and PEH formation in lumbar micoroendoscopic surgery. STUDY DESIGNThis is a randomized controlled trial (RCT) with additional prospective observational cohort. PATIENT SAMPLEPatients were registered from July 2017 to September 2018 and a hundred and three patients undergoing microendoscopic laminectomy for lumbar spinal stenosis at a single institution were enrolled in this study. OUTCOME MEASURESThe primary outcome was the drainage volume within 48 hours after surgery. Secondary outcomes were the numerical rating scale (NRS) of leg pain on the second (NRS2) and seventh day (NRS7) after surgery and the hematoma area ratio (HAR) in horizontal images on magnetic resonance image (MRI). METHODSIn the RCT, 41 cases that received TGTMS (F group) were compared with 41 control group cases (C group) that did not receive TGTMS at the end of the procedure. Drainage volume, NRS2, NRS7, and HAR on MRI were evaluated. Nineteen cases were excluded from the RCT (I group) due to difficulty of hemostasis during surgery and the intentional use of TGTMS for hemostasis. I group was compared with C group in the drainage volume and NRS of leg pain as a prospective observational study. RESULTSThe RCT demonstrated no statistically significant difference in drainage volume between those receiving TGTMS (117.0±71.7; mean±standard deviation) and controls (125.0±127.0; p=.345). The NRS2 and NRS7 was 3.5±2.6 and 2.8±2.5 in the F group, respectively, and 3.1±2.6 and 2.1±2.3 in the C group, respectively. The HAR on MRI was 0.19±0.19 in the F group and 0.17±0.13 in the C group. There was no significant difference in postoperative leg pain and HAR (p=.644 for NRS2, p=.129 for NRS7, and p=.705 for HAR). In the secondary observational cohort, the drainage volume in the I group was 118.3±151.4, and NRS2 and NRS7 was 3.5±2.0 and 2.6±2.6, respectively. There were no statistically significant differences in drainage volume (p=.386) or postoperative NRS of leg pain between these two groups (p=.981 and .477 for NRS2 and NRS7, respectively). CONCLUSIONSThe prophylactic use of TGTMS in patients undergoing microendoscopic laminotomy for lumbar spinal stenosis did not demonstrate any difference in postoperative bleeding or PEH. Nonetheless, for patients that had active bleeding that required the use of TGTMS, there was no evidence of difference in postoperative clinical outcomes relative to controls.

EXTH-24. INCREASING THERAPEUTIC INDUCED NEURAL STEM CELL PERSISTENCE IN THE GLIOBLASTOMA TUMOR RESECTION CAVITY

Abstract BACKGROUND Induced neural stem cells (iNSCs) have emerged as a promising therapeutic platform for glioblastoma (GBM). iNSCs have the innate ability to home to tumor foci, making them ideal carriers for anti-tumor payloads. However, iNSC persist for only two weeks in the murine GBM tumor resection cavity. We hypothesized that, by encapsulating iNSCs in a scaffold matrix, we could increase both the persistence of the cells the therapeutic durability. METHODS iNSCs expressing TRAIL were encapsulated in a gelatin-thrombin matrix; fibrinogen was used to polymerize the matrix. SEM was used to explore interactions between iNSCs and the scaffold matrix. To evaluate persistence, iNSCs encapsulated in the matrix were implanted into mock resection cavities of athymic nude mice and followed via BLI. To study the impacts of encapsulation on iNSC efficacy, athymic nude mice were implanted with U87 or GBM8 tumors. Tumors were then resected, and iNSCs encapsulated in the matrix were implanted; tumor volume was monitored via BLI. RESULTS SEM images showed homogeneous distribution of iNSCs throughout the matrix; iNSCs were completed encased in the fibrin clot component of the matrix and did not adhere to gelatin. In vivo, encapsulated iNSCs persisted for nearly 100 days whereas iNSCs directly injected into the brain parenchyma persisted &amp;lt; 20 days. Using mice bearing GBM8 tumors, animals treated with a high dose of therapeutic encapsulated iNSCs survived ~60 days longer than animals treated with non-therapeutic cells. A similar trend was observed in animals inoculated with U87 tumors. While not statistically significant, 25% of mice treated with iNSCs encapsulated in the gelatin-thrombin matrix survived longer than those treated with iNSCs encapsulated in a fibrin-only matrix, suggesting additional benefit due to the gelatin component. FUTURE DIRECTIONS Prospective experiments will explore the impact of the scaffold on iNSC phenotype, including proliferation, differentiation, and migration markers.

Effectiveness of Gelatin-Thrombin Matrix Sealants (Floseal®) on Postoperative Spinal Epidural Hematoma during Single-Level Lumbar Decompression Using Biportal Endoscopic Spine Surgery: Clinical and Magnetic Resonance Image Study.

Background Symptomatic postoperative spinal epidural hematoma (PSEH) is a devastating complication that could develop after lumbar decompression surgery. PSEH can also develop after biportal endoscopic spine surgery (BESS), one of the recently introduced minimally invasive spine surgery techniques. Gelatin-thrombin matrix sealant (GTMS) is commonly used to prevent PSEH. This study aimed at analyzing the clinical and radiological effects of GTMS use during BESS. Methods A total of 206 patients with spinal stenosis who underwent decompression by BESS through a posterior interlaminar approach from October 2015 to September 2018 were enrolled in this study. Postoperative magnetic resonance imaging (MRI) was performed in all patients for evaluation of PSEH. Patients in whom GTMS was not used during surgery were assigned to Group A, and those in whom GTMS was used were classified as Group B. In the clinical evaluation, the visual analog scale (VAS) of the leg and back, Oswestry Disability Index (ODI), and modified MacNab criteria were used. The incidence rate and degree of dural compression of PSEH on postoperative MRI were measured. Results The average age of the patients was 68.1 ± 11.2 (42–89) years. The overall incidence rate of PSEH was 20.9% (43/206). The incidence rates in Groups A and B were 26.4% and 13.6%, respectively, showing a significant difference (p = 0.023). The VAS-leg and ODI improvement was significantly different depending on the intraoperative use of GTMS. However, there was no statistically significant difference between the two groups in terms of the VAS-back improvement. Groups A and B showed “good” and “excellent” rates according to the modified MacNab criteria in 79.4% and 87.6% of patients, respectively, showing statistically significant difference (p = 0.049). In Group A, two patients underwent revision surgery due to PSEH, while none in Group B had such event. Conclusion Intraoperative use of GTMS during BESS may be related to reduction in the occurrence rate of PSEH. Specifically, patients with GTMS appliance showed marked decrease in the occurrence of PSEH and had better clinical outcomes.

An Efficacy Comparison of Two Hemostatic Agents in a Porcine Liver Bleeding Model: Gelatin/Thrombin Flowable Matrix versus Collagen/Thrombin Powder

Purpose: Management of bleeding during surgery can be aided by the application of topical hemostatic agents. This study compared the hemostatic efficacy of a new powder agent containing collagen, chondroitin sulfate, and thrombin (PCCT) with a flowable gelatin-thrombin matrix with smooth particles (SmGM) in a porcine liver bleeding model. Materials and Methods: Lesions 4–6 mm deep and ∼10 mm in diameter were created in porcine livers and treated with either SmGM or PCCT. Bleeding rate and grade were quantified before and 3, 7, and 11 minutes after treatment. Results: Thirty-two lesions each were treated with SmGM or PCCT; the median (Q1, Q3) initial bleeding rate was comparable between the two groups (8.43 [6.18, 10.68] g/min and 7.15 [5.16, 9.63] g/min, respectively). The residual bleeding rate was significantly lower at all time-points post treatment for SmGM compared with PCCT (3 minutes: 0.14 [0.07, 0.21] versus 0.46 [0.20, 1.20] g/min, p < 0.0001; 7 minutes: 0.07 [0.04, 0.11] versus 0.12 [0.08, 0.39] g/min, p = 0.001; 11 minutes: 0.05 [0.03, 0.08] versus 0.07 [0.05, 0.12] g/min, p = 0.043). Bleeding grade at 3 minutes was also significantly lower for SmGM compared with PCCT (median [Q1, Q3] 0.0 [0.0, 0.0] versus 1.0 [1.0, 2.0], p < 0.0001). PCCT required reapplication in approximately one-third of applications due to insufficient hemostasis 4 minutes after initial application and showed a tendency to stick to the wet gauze during approximation. Conclusions: In this bleeding model, treatment with SmGM resulted in reduced blood loss, no need for reapplication and was easier to apply compared with PCCT.

Use of a gelatin-thrombin hemostatic matrix in obstetrics and gynecological surgery

Gelatin-thrombin matrix (GTM) is a hemostatic sealant consisting of bovine-derived gelatin matrix and human-derived thrombin, combining both mechanical and active mechanisms to achieve hemostasis. It was approved by the Food and Drug Administration in 1999. GTM has been used by several surgical specialties; however, it is a possibly an under-used tool in obstetrics and gynecology. A limited number of studies have been performed on its use during laparoscopic endometrioma excision and myomectomy. It may prove useful in endometrioma excision in reproductive aged women because it is likely to harm ovarian reserve less than electrocautery; however, this conclusion needs to be validated. The only study on GTM use in myomectomy included 50 women randomized into GTM and control groups, and showed decreased blood loss and shorter hospital stays in the GTM group. In gynecologic oncology, it was successfully used to reduce lymphocele cases in a cohort study. GTM has been used successfully in obstetrics in a handful of cases of uncontrolled bleeding from caesarean scar, placental site, ectopic pregnancy, rectovaginal hematoma, and venous plexus over the vaginal vault after emergency postpartum hysterectomy. Risk of viral transmission is a major concern about GTM, yet there are no reports on disease transmission with GTM use to date. Rare but serious adverse effects and complications have been reported such as fatal or near-fatal thromboembolism and small bowel obstruction. Although GTM is mostly a safe product, it is still not free of complications and risks. In conclusion, although routine use of GTM cannot be recommended due to concerns about its safety, cost, and availability, it may prove useful when conventional hemostatic methods such as suturing and electrocauterization fail or are not appropriate.

Efficacy of Topical Hemostatic Agents: A Comparative Evaluation of Two Gelatin/Thrombin-Based Hemostatic Matrices in a Porcine Kidney Surgical Model

Purpose: Topical hemostatic agents are an important means of controlling or preventing bleeding. This study was performed to compare gelatin–thrombin matrix with smooth particles (SmGM) versus gelatin–thrombin matrix with stellate particles (StGM) in a porcine kidney bleeding model. Materials and methods: In male pigs, reproducible lesions (diameter and depth ∼10 mm) were created in the renal cortex. Each lesion was treated topically using either SmGM or StGM. Blood loss was quantified before and 2, 5 and 10 minutes after treatment. Dry mass, ultrastructural and histologic analyses were also performed. Results: Thirty-two lesions were treated with SmGM and 32 with StGM; median initial bleeding rates were 27.6 and 29.1 mL/min, respectively. Two minutes post-application, SmGM was associated with significantly less bleeding than StGM (0.574 vs 0.920 mL/min; p < .0001). This difference stemmed principally from lesions with initial blood loss >29 mL/min, where bleeding rates at 2 minutes were ∼3-fold higher with StGM (1.636 vs 0.567 mL/min; p ≥ 0.040). Dry mass per unit volume of hemostatic agent was significantly higher with SmGM versus StGM. SmGM formed discrete, smooth particles, while StGM particles were stellate and tended to coalesce. Histologic analysis showed more solid mass, larger particles and less intervening space with SmGM versus StGM. Conclusions: In a severe, high-volume bleeding model, residual bleeding at 2 minutes was significantly lower with SmGM versus StGM, and SmGM showed greater consistency across bleeding intensities. These findings may be attributable to dry mass per unit volume and/or ultrastructural differences between the two agents.

Improvement of Perioperative Outcomes in Major Gynecological and Gynecologic-Oncological Surgery with Hemostatic Gelatin-Thrombin Matrix.

To assess the impact of the use of intraoperative hemostatic gelatin-thrombin matrix (HM) (Floseal®, Baxter Healthcare) on transfusion rates and short-term perioperative outcomes in gynecological surgery. In this retrospective, single-center study, we evaluated data of 215 patients (83 cases and 132 controls) undergoing extensive gynecological surgery (e.g. oncological procedures) with and without intraoperative HM application. Cases and controls did not differ according to age, preoperative hemoglobin (Hb) concentration, and Hb or C-reactive protein (CRP) levels at discharge. Patients receiving HM had significantly reduced operative (168 vs. 199 min, p=0.02) and hospitalization (9 vs. 14 days, p<0.001) times. The mean postoperative Hb drop (3.33 vs. 4.51 g/dl, p<0.001), and the mean postoperative increase in CRP (94.9 vs. 149.1 mg/l, p<0.001) were significantly less pronounced within the HM group. Despite more prevalent coagulopathy (48 vs. 31%, p=0.02), e.g. due to anticoagulant use (15.7 vs. 3%, p<0.001), patients treated using HM needed less frequent transfusions of packed red blood cells [odds ratio (OR)= 0.13, 95% confidence interval (CI)=0.07-0.24) and fresh frozen plasma (OR=0.51, 95% CI=0.24-1.05). In comparison to controls, the need for surgical revisions (OR 0.1, CI 95% 0.02-0.42) and intensive-care unit admissions (OR 0.15, 95% CI=0.08-0.30) was lower in patients treated with HM. To our knowledge, our study is the largest case-control study focusing on Floseal® use in gynecology. The use of HM was associated with significantly better short-term perioperative outcomes. Due to its local action, HM seems to be particularly useful in patients in which anticoagulant medication cannot be paused.

Is the use of hemostatic matrix (Floseal) and alkylene oxide copolymer (Ostene) safe in spinal laminectomies? Peridural fibrosis assessment

ObjectiveFailed Back Syndrome (FBS) is unacceptable relief of pain or recurrence of symptoms in patients after spinal surgery, such as laminectomy. One possible cause of FBS is peridural fibrosis (PF). PF is the overproduction of scar tissue adjacent to the dura mater. Bleeding can cause PF after laminectomy. Ostene is an alkylene oxide copolymer material used to stop bleeding from bony surfaces. Floseal is a gelatin thrombin matrix sealant used to assist fibrin formation and to promote coagulation. MethodsTotal of 32 female Sprague–Dawley rats were evenly allotted to 4 experimental groups: laminectomy only, laminectomy + Ostene (Baxter International, Inc., Deerfield, IL, USA), laminectomy + Floseal (Baxter International, Inc., Deerfield, IL, USA), and laminectomy + Adcon-L (aap Implantate AG, Berlin, Germany). After performing total laminectomy, agents were placed over dura mater. Spinal column of test subjects was harvested 6 weeks after laminectomy. Histopathological examination of samples was based on Masson's trichrome and hematoxylin and eosin staining. PF observed in the groups was graded using system previously described by He et al. Statistically significant p value was defined as p < 0.005. ResultsPresent study revealed that Adcon-L, Ostene, and Floseal groups had reduced PF compared with laminectomy only group (p = 0.001). Comparison of Ostene and Floseal groups with Adcon-L group yielded no significant difference. ConclusionReoperation as result of FBS has greater risk and often has poor outcome; surgeons must take precautions to avoid FBS, such as careful selection of appropriate patient and operation technique. Ostene and Floseal may be applied and left in the operation field safely during laminectomy to reduce occurrence of PF after procedure.

Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study

ObjectiveThis prospective randomized controlled pilot study aimed to find whether gelatin-thrombin matrix used as a tissue sealant (FloSeal) can prevent the occurrence of pelvic lymphocele in patients with gynecologic cancer who has undergone pelvic lymphadenectomy.MethodsEach patient, who undergo a laparotomic pelvic lymph node dissection on both sides, was randomly assigned for FloSeal application on 1 side of the pelvis. The other side of the pelvis without any product application being the control side. The amount of lymph drainage at each side of the pelvis was measured for 3 days, and computed tomography scans were obtained 7 days and 6 months after surgery for detection of pelvic lymphocele.ResultsAmong 37 cases, the median amount of lymph drainage was significantly decreased in the hemi-pelvis treated with FloSeal compared to the control hemi-pelvis (p=0.025). The occurrence of lymphocele was considerably reduced in treated hemi-pelvis (8/37, 21.6%) compared with control hemi-pelvis (12/37, 32.4%) after 7 post-operative days (p=0.219), and more decreased in the treated hemi-pelvis (5/37, 13.5%) compared with control hemi-pelvis (9/37, 24.3%) after postoperative 6 months (p=0.344).ConclusionThe application of FloSeal as a tissue sealant in lymph nodes resected tissues can reduce the incidence of pelvic lymphocele in gynecologic cancer patients. A large randomized controlled study could confirm these preliminary results.

Gelatin-thrombin hemostatic matrix in neurosurgical procedures: hemostatic effectiveness and economic value of clinical and surgical procedure-related benefits.

Gelatin-thrombin hemostatic matrix (FloSeal®) use is associated with shorter surgical times and less blood loss, parameters that are highly valued in neurosurgical procedures. We aimed to assess the effectiveness of gelatin-thrombin in neurosurgical procedures and estimate its economic value. In a 6-month retrospective evaluation at 2 hospitals, intraoperative and postoperative information were collected from patients undergoing neurosurgical procedures where bleeding was controlled with gelatin-thrombin matrix or according to local bleeding control guidelines (control group). Study endpoints were: length of surgery, estimated blood loss, hospitalization duration, blood units utilized, intensive care unit days, postoperative complications, and time to recovery. Statistical methods compared endpoints between the gelatin-thrombin and control groups and resource utilization costs were estimated. Seventy-eight patients (38 gelatin-thrombin; 40 control) were included. Gelatin-thrombin was associated with a shorter surgery duration than control (166±40 versus 185±55 minutes, P=0.0839); a lower estimated blood loss (185±80 versus 250±95 mL; P=0.0017); a shorter hospital stay (10±3 versus 13±3 days; P<0.001); fewer intensive care unit days (10 days/3 patients and 20 days/4 patients); and shorter time to recovery (3±2.2 versus 4±2.8 weeks; P=0.0861). Fewer gelatin-thrombin patients experienced postoperative complications (3 minor) than the control group (5 minor; 3 major). No gelatin-thrombin patient required blood transfusion; 5 units were administered in the control group. The cost of gelatin-thrombin (€ 268.40/unit) was offset by the shorter surgery duration (difference of 19 minutes at € 858/hour) and the economic value of improved the other endpoint outcomes (i.e., shorter hospital stay, lesser blood loss/lack of need for transfusion, fewer intensive care unit days, and complications). The use of gelatin-thrombin hemostatic matrix in patients undergoing neurosurgical procedures was associated with better intra- and postoperative parameters than conventional hemostasis methods, with these parameters having substantial economic benefits.