RESUMO
Background: Efficient hemostasis during lumbar surgery (LS) is associated with better perioperative outcomes. Flowable gelatin hemostatic matrix (FGHM) is a new type of absorbable hemostatic agent, which is effective to control bleeding during spinal surgery. This study aimed to assess the impact of FGHM on perioperative outcomes and hospital costs associated with LS. Methods: This study retrospectively analyzed medical and billing records of patients who underwent LS for spinal degenerative disease in a Chinese tertiary care hospital from 2014 to 2016. The identified patients were further stratified into a FGHM group (n = 108) (using the combination of FGHM and gelatin sponge) and a historical control group (using oxidized cellulose and/or collagen, n = 82) for the adjusted comparisons of the perioperative outcomes using a propensity score matching method. Multiple generalized linear regression was conducted to assess the impact of using FGHM on total hospitalization costs. Results: Comparisons of 64 propensity score matched pairs showed a significantly lower blood transfusion rate (34.4% vs 64.1%, p = 0.005), lower blood transfusion volume (182.7 ± 312.4 vs 301.3 ± 281.0 mL, p = 0.045), reduced post-surgery drainage tube placement rate (82.8% vs 93.8%, p = 0.046), and shorter post-operative days on antibiotics (6.0 ± 2.6 vs 7.1 ± 2.4 days, p = 0.010) in the FGHM group. Although with a relatively high acquisition price, the use of FGHM for hemostasis in LS did not increase the total hospitalization costs (coefficient = -0.001, p = 0.972). Conclusions: The use of FGHM in LS improved perioperative outcomes related to hemostatic effects without increasing overall hospital costs in a real-world hospital setting.
Assuntos
Esponja de Gelatina Absorvível/economia , Esponja de Gelatina Absorvível/uso terapêutico , Vértebras Lombares/cirurgia , Fusão Vertebral/métodos , Adulto , Idoso , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Transfusão de Sangue/estatística & dados numéricos , Celulose Oxidada/economia , Celulose Oxidada/uso terapêutico , China , Colágeno/economia , Colágeno/uso terapêutico , Feminino , Humanos , Tempo de Internação , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Pontuação de Propensão , Características de Residência , Estudos Retrospectivos , Fatores Socioeconômicos , Centros de Atenção Terciária/economia , Centros de Atenção Terciária/estatística & dados numéricosRESUMO
OBJECTIVE: We investigated the medical costs and effects of ofloxacin drops (OFLX), gelatin sponge patches, spontaneous healing, and endoscopic myringoplasty on healing in large tympanic membrane perforations (TMPs). METHODS: In total, 100 patients with large traumatic TMPs involving >50% of the eardrum were randomly assigned to OFLX, gelatin sponge, spontaneous healing, or endoscopic myringoplasty treatment groups. Medical costs, closure times, and closure rates were compared among groups at 6â¯months. RESULTS: The closure rates in the OFLX, gelatin sponge, spontaneous healing, and endoscopic myringoplasty groups were 95.7%, 82.6%, 58.3%, and 91.7%, respectively (Pâ¯=â¯0.05). The mean closure time was 13.73⯱â¯6.14â¯days in the OFLX group, 15.89⯱â¯4.95â¯days in the gelatin sponge group, 48.36⯱â¯10.37â¯days in the spontaneous healing group, and 12â¯days in the endoscopic myringoplasty group (Pâ¯<â¯0.001). The mean medical costs in US dollars were $15.53⯱â¯3.15, $103.64⯱â¯111.58, $11.17⯱â¯1.33, and $715.90 in the OFLX, gelatin sponge, spontaneous healing, and endoscopic myringoplasty groups, respectively (Pâ¯<â¯0.001). CONCLUSION: Although the gelatin sponge and myringoplasty treatments significantly shortened the closure time compared with spontaneous healing, the gelatin sponge patch did not significantly improve the closure rate, and the medical cost of myringoplasty was significantly higher than that of the other treatments. In contrast, OFLX significantly shortened closure time and had a higher closure rate than spontaneous healing, and the medical costs were lower than those of the gelatin sponge and myringoplasty procedures.
Assuntos
Endoscopia/economia , Esponja de Gelatina Absorvível/economia , Custos de Cuidados de Saúde , Miringoplastia/economia , Ofloxacino/economia , Perfuração da Membrana Timpânica/terapia , Adulto , Antibacterianos/economia , Antibacterianos/uso terapêutico , Feminino , Esponja de Gelatina Absorvível/uso terapêutico , Hemostáticos/economia , Hemostáticos/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Ofloxacino/uso terapêutico , Perfuração da Membrana Timpânica/economia , Cicatrização , Adulto JovemRESUMO
OBJECTIVE: To present an alternative cost-effective hemostatic agent (HA) for cranial surgery and to describe the technique to produce it. METHODS: This HA has been used in 3 reference centers over the last year during 230 procedures, including different types of pathology, such as skull base, oncology, vascular, and trauma, either for endoscopic or open approaches. This agent was made from a low-cost and worldwide-available gelatin foam which was mixed with saline solution in 2 syringes and connected by a 3-way stopcock, making a useful hemostatic paste. RESULTS: The cost was 16 and 28 times less than SURGIFLO and FLOSEAL, respectively. The mean time to prepare the mix was 4 minutes. It was very effective for venous and low-flow bleeding. CONCLUSIONS: The presented technique offers a reliable and cost-effective way of achieving hemostasis in cranial surgery, therefore allowing hospitals with limited resources to perform advanced procedures in a safer way.
Assuntos
Gelatina/economia , Gelatina/uso terapêutico , Hemostáticos/economia , Hemostáticos/uso terapêutico , Procedimentos Neurocirúrgicos/economia , Perda Sanguínea Cirúrgica/prevenção & controle , Análise Custo-Benefício , Esponja de Gelatina Absorvível/economia , Técnicas Hemostáticas/economia , Técnicas Hemostáticas/instrumentação , Humanos , Procedimentos Neurocirúrgicos/métodos , Crânio/cirurgia , Trombina/economia , Fatores de TempoRESUMO
BACKGROUND: A five-year retrospective database analysis comparing the use of Floseal 1 flowable topical hemostat alone (F) and in combination with gelatin/thrombin (F + G/T) to achieve hemostasis and control surgical bleeding showed higher resource utilization for F + G/T cases relative to F matched pairs during spinal surgery. Lower resource use in the F group was characterized by shorter hospital length of stay and surgical time as well as fewer blood transfusions and less hemostat agent used per surgery. OBJECTIVE: To evaluate the cost-consequence of using F compared to F + G/T in minor, major and severe spinal surgery from the US hospital perspective. METHODS: A cost-consequence model was developed using the US hospital perspective. Model inputs include clinical inputs from the literature, cost inputs (hemostatic matrices, blood product transfusion, hospital stay and operating room time) from the literature, and an analysis of annual spine surgery volume (minor, major and severe) using the 2012 National Inpatient Sample (NIS) database. Costs are reported in 2017 US dollars. One-way and probabilistic sensitivity analyses address sources of variability in the results. RESULTS: A medium-volume hospital (130 spine surgeries per year) using F versus F + G/T for spine surgeries is expected to require 85 less hours of surgical time, 58 fewer hospital days and 7 fewer blood transfusions in addition to hemostat volume savings (F: 1 mL, thrombin: 1994 mL). The cost savings associated with the hospital resources for a medium-volume hospital are expected to be $317,959 (surgical hours = $154,746, hospital days = $125,237, blood transfusions = $19,023, hemostatic agents = $18,953) or $2445 per spine surgery. CONCLUSIONS: The use of F versus F + G/T could lead to annual cost savings for US hospitals performing a low to high volume of spinal surgeries per year.
Assuntos
Esponja de Gelatina Absorvível/economia , Esponja de Gelatina Absorvível/uso terapêutico , Hemostáticos/economia , Hemostáticos/uso terapêutico , Procedimentos Neurocirúrgicos/métodos , Perda Sanguínea Cirúrgica/prevenção & controle , Transfusão de Sangue/estatística & dados numéricos , Análise Custo-Benefício , Quimioterapia Combinada , Gelatina/economia , Gelatina/uso terapêutico , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Humanos , Tempo de Internação , Duração da Cirurgia , Estudos Retrospectivos , Trombina/economia , Trombina/uso terapêuticoRESUMO
OBJECTIVES/HYPOTHESIS: To evaluate the cost-effectiveness of Floseal, a topically applied hemostatic agent, and nasal packing for the management of epistaxis in Canada. STUDY DESIGN: Outcomes research, a cost-utility analysis. METHODS: We developed a Markov model to compare the costs and health outcomes of Floseal with nasal packing over a lifetime horizon from the perspective of a publicly funded healthcare system. A cycle length of 1 year was used. Efficacy of Floseal and packing was sought from the published literature. Unit costs were gathered from a hospital case costing system, whereas physician fees were extracted from the Ontario Schedule of Benefits for Physician Services. Results were expressed as an incremental cost per quality-adjusted life year (QALY) gained. A series of one-way sensitivity and probabilistic sensitivity analyses were performed. RESULTS: From the perspective of a publicly funded health are system, the Floseal treatment strategy was associated with higher costs ($2,067) and greater QALYs (0.27) than nasal packing. Our findings were highly sensitive to discount rates, the cost of Floseal, and the cost of nasal packing. The probabilistic sensitivity analysis suggested that the probability that Floseal treatment is cost-effective reached 99% if the willingness-to-pay threshold was greater than $120,000 per QALY gained. CONCLUSIONS: Prior studies have demonstrated Floseal to be an effective treatment for anterior epistaxis. In the Canadian healthcare system, Floseal treatment appears to be a cost-effective treatment option compared to nasal packing for anterior epistaxis. LEVEL OF EVIDENCE: 2c Laryngoscope, 1778-1782, 2018.
Assuntos
Epistaxe/economia , Epistaxe/terapia , Esponja de Gelatina Absorvível/economia , Hemostáticos/economia , Tampões Cirúrgicos/economia , Canadá , Análise Custo-Benefício , Custos Hospitalares/estatística & dados numéricos , Humanos , Cadeias de Markov , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de VidaRESUMO
BACKGROUND: Epistaxis is the most common emergent consultation to otolaryngology-head & neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal® (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy and cost-effectiveness of Floseal® (Baxter, USA) compared to traditional nasal packing for persistent epistaxis. METHODS: A prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal® (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 h post-treatment, and 2) self-reported patient comfort at 48 h post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed. RESULTS: There were no significant differences between groups for initial hemostasis (76.9% vs. 84.6%, p = 1.000) or, hemostasis at 48 h (76.9% vs. 69.2%, p = 1.000), requirement for admission (15.4% vs. 46.1%, p = 0.2016) or 30-day re-presentation rates (15.4% vs. 46.1%, p = 0.2016). Floseal® (Baxter, USA) was superior for decreased pain during placement (2.42 vs. 7.77, p = 0.0022), treatment (0.50 vs. 4.46, p = 0.0007) and removal (0 vs. 3.85, p = 0.0021). Floseal® (Baxter, USA) provides an average $1567.61 per patient savings from the single-payer system point of view and has an ICER of - $11,891 per re-bleed prevented (95% CI: -$37,658 to +$473). Uncertainty analysis shows that Floseal® has >90% chance of not only being cost-effective, but the dominant (preferred) treatment. CONCLUSIONS: Floseal® (Baxter, USA) was demonstrated to be an effective, comfortable and cost-effective alternative treatment of persistent epistaxis when compared to traditional packing methods for patients referred to OHNS with a normal coagulation profile. TRIAL REGISTRATION: Trial registration number: NCT02488135 . Date registered: June 26, 2015.
Assuntos
Epistaxe/terapia , Esponja de Gelatina Absorvível/uso terapêutico , Técnicas Hemostáticas , Hemostáticos/uso terapêutico , Adulto , Idoso , Análise de Variância , Canadá , Intervalos de Confiança , Análise Custo-Benefício , Epistaxe/diagnóstico , Feminino , Esponja de Gelatina Absorvível/economia , Hemostáticos/economia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Índice de Gravidade de Doença , Tampões Cirúrgicos/estatística & dados numéricos , Resultado do TratamentoRESUMO
OBJECTIVES: A recently published retrospective analysis comparing two different active flowable hemostatic matrices (FLOSEAL and SURGIFLO Kit with Thrombin) showed significantly increased resource use and complications (surgery time, risk of blood product transfusion, and amount of matrix used) with SURGIFLO use compared to FLOSEAL in major spine surgery, and also significantly increased surgical time with SURGIFLO use in severe spine surgery. This analysis was developed as a follow-up to this prior analysis, to evaluate the cost-consequence of using FLOSEAL vs SURGIFLO in major and severe spine surgery. METHODS: A cost consequence model was constructed from a US hospital provider perspective. Model parameters combined clinical inputs from the published retrospective analysis with supplemental analyses on annual spine surgery volume using the 2012 National Inpatient Sample (NIS) database. Cost of hemostatic matrices, blood product transfusion, and operating room time were identified from published literature. Various one-way and probabilistic sensitivity analyses were performed. RESULTS: The base case for a medium volume hospital showed that, compared to SURGIFLO, patients receiving FLOSEAL required three fewer blood product transfusions and saved 27 h of OR time, resulting in annual savings of $151 per major and $574 per severe spine surgery. Additional scenarios for high and low volume hospitals supported cost savings in the base case. Probabilistic sensitivity analysis revealed FLOSEAL was cost-saving in 76% of simulations in major spine and 97% of iterations in severe spine surgery. CONCLUSIONS: This economic analysis indicates that use of FLOSEAL instead of SURGIFLO hemostatic matrices to induce hemostasis in both major and severe spine surgery could potentially lead to sizable cost savings in US hospitals, regardless of spinal surgery case-mix.
Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Esponja de Gelatina Absorvível/economia , Hemostáticos/economia , Procedimentos Neurocirúrgicos/economia , Procedimentos Neurocirúrgicos/métodos , Transfusão de Sangue/economia , Transfusão de Sangue/estatística & dados numéricos , Análise Custo-Benefício , Custos Hospitalares/estatística & dados numéricos , Humanos , Modelos Econométricos , Procedimentos Neurocirúrgicos/efeitos adversos , Duração da Cirurgia , Complicações Pós-Operatórias/economia , Complicações Pós-Operatórias/epidemiologia , Estudos RetrospectivosRESUMO
BACKGROUND: A recent retrospective comparative effectiveness study found that use of the FLOSEAL Hemostatic Matrix in cardiac surgery was associated with significantly lower risks of complications, blood transfusions, surgical revisions, and shorter length of surgery than use of SURGIFLO Hemostatic Matrix. These outcome improvements in cardiac surgery procedures may translate to economic savings for hospitals and payers. OBJECTIVE: The objective of this study was to estimate the cost-consequence of two flowable hemostatic matrices (FLOSEAL or SURGIFLO) in cardiac surgeries for US hospitals. METHODS: A cost-consequence model was constructed using clinical outcomes from a previously published retrospective comparative effectiveness study of FLOSEAL vs SURGIFLO in adult cardiac surgeries. The model accounted for the reported differences between these products in length of surgery, rates of major and minor complications, surgical revisions, and blood product transfusions. Costs were derived from Healthcare Cost and Utilization Project's National Inpatient Sample (NIS) 2012 database and converted to 2015 US dollars. Savings were modeled for a hospital performing 245 cardiac surgeries annually, as identified as the average for hospitals in the NIS dataset. One-way sensitivity analysis and probabilistic sensitivity analysis were performed to test model robustness. RESULTS: The results suggest that if FLOSEAL is utilized in a hospital that performs 245 mixed cardiac surgery procedures annually, 11 major complications, 31 minor complications, nine surgical revisions, 79 blood product transfusions, and 260.3 h of cumulative operating time could be avoided. These improved outcomes correspond to a net annualized saving of $1,532,896. Cost savings remained consistent between $1.3m and $1.8m and between $911k and $2.4m, even after accounting for the uncertainty around clinical and cost inputs, in a one-way and probabilistic sensitivity analysis, respectively. CONCLUSIONS: Outcome differences associated with FLOSEAL vs SURGIFLO that were previously reported in a comparative effectiveness study may result in substantial cost savings for US hospitals.
Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Cirúrgicos Cardíacos/economia , Procedimentos Cirúrgicos Cardíacos/métodos , Hemostáticos/economia , Transfusão de Sangue/economia , Transfusão de Sangue/estatística & dados numéricos , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Análise Custo-Benefício , Esponja de Gelatina Absorvível/economia , Humanos , Modelos Econométricos , Salas Cirúrgicas/economia , Duração da Cirurgia , Complicações Pós-Operatórias/economia , Complicações Pós-Operatórias/epidemiologia , Reoperação/economia , Reoperação/estatística & dados numéricos , Estudos RetrospectivosRESUMO
OBJECTIVE: To share our experience with a new delivery system for the flowable hemostatic matrix, FloSeal, in endoscopic and microscopic skull base surgery. METHODS: We prospectively analyzed the use of FloSeal with a hemostatic delivery system in transnasal endoscopic and microscopic skull base procedures performed at the authors' institution from January 1, 2015, to June 30, 2015. In all cases the number of aliquots was noted for the entire operation, and the total number of FloSeal ampules of 5 mL was also recorded. RESULTS: Our device allowed controlled application of small amounts (0.5-1 mL) of FloSeal to the site of bleeding. This controlled application resulted not only in increased visibility during its application, but it also reduced the amount of FloSeal required during the procedure. We were able to use 5-10 applications per 5-mL ampule of FloSeal within an individual procedure. No procedure required more than one 5-mL ampule of FloSeal. Therefore, the use of our device results in a reduction of costs. Prior to the use of our device, we were often only able to use 1 vial of 5 ml of material for 1 or 2 applications, especially in transnasal endoscopic procedures when working along a deep corridor. CONCLUSIONS: Our results indicate that our delivery device of FlowSeal can effectively control hemostasis by applying small amounts of FlowSeal to the site of bleeding. This results in increased visibility during hemostasis and a reduction of cost.
Assuntos
Esponja de Gelatina Absorvível/administração & dosagem , Microcirurgia/economia , Microcirurgia/instrumentação , Neuroendoscopia/economia , Neuroendoscopia/instrumentação , Base do Crânio/cirurgia , Análise Custo-Benefício , Esponja de Gelatina Absorvível/economia , Técnicas Hemostáticas/economia , Técnicas Hemostáticas/instrumentação , Humanos , Cavidade Nasal/cirurgia , Estudos ProspectivosRESUMO
INTRODUCTION: SURGIFLO and FLOSEAL are absorbable gelatin-based products that form hemostatic matrices. These products are indicated as adjuncts to hemostasis when control of bleeding by conventional surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. This study analyzed the effect of surgery time and the choice of product on cost to the hospital and patient outcomes. METHODS: The data source was the Premier Hospital database from January 1, 2010-June 30, 2012. Eligible patients were ≥18 years of age with a spinal fusion or refusion surgery with either SURGIFLO (Ethicon Inc.) or FLOSEAL (Baxter International Inc.). The hospital Charge Master was used to identify the amount of flowable product, whether it included Thrombin, and the cost. Multivariable models were performed on overall cost and likelihood of surgical complications. All models were adjusted for patient demographics and severity as well as hospital, and surgical characteristics. RESULTS: A total of 24,882 patient records from 121 hospitals were analysed, which included 15,088 FLOSEAL records and 9794 SURGIFLO records, with 1498 SURGIFLO with Thrombin patients. Little or no differences in surgical complications were found between surgeries with SURGIFLO vs. surgery with FLOSEAL. Regression models showed a reduction in cost of $65 associated with use of SURGIFLO with Thrombin and an additional $21 reduction in hospital cost for each additional hour of surgery. Modeling which accounts for hospital fixed effects suggest that, in addition to a gap of â¼$300 favoring SURGIFLO with Thrombin, every additional hour of surgery was associated with an additional reduction in hospital costs of â¼$26. CONCLUSIONS: While the choice of flowable product had no effect on clinical outcomes, use of SURGIFLO was associated with hospital cost savings for flowable product. These savings increased with the length of surgery, even when controlling for the amount of flowable product (mL) used.
Assuntos
Esponja de Gelatina Absorvível/economia , Hemostáticos/economia , Custos Hospitalares/estatística & dados numéricos , Trombina/economia , Adulto , Idoso , Feminino , Esponja de Gelatina Absorvível/uso terapêutico , Hemostáticos/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Análise de Regressão , Fusão Vertebral , Dispositivos de Fixação Cirúrgica , Trombina/uso terapêuticoRESUMO
BACKGROUND: Surgical bleeding can be associated with an increased risk of morbidity and mortality across all surgical areas. Thus, numerous products have been developed to achieve haemostasis. A flowable haemostatic matrix such as Floseal® can quickly and reliably stop bleeding across the full spectrum of bleeding scenarios. The aim of this study was to systematically review clinical and economic evidence regarding the use of Floseal® in surgical procedures. METHODS: An extensive literature search was conducted in PubMed, EMBASE, and the Cochrane Library over the period spanning 2003-2013 to identify publications related to Floseal® use in all types of surgical procedures. Case reports and case series studies were excluded. RESULTS: A total of 27 papers met the selection criteria and were analysed. In the studies, blood loss and the time to achieve haemostasis were the most reported outcomes used to assess the efficacy of Floseal®. The majority of published studies (64%) examined the use of Floseal® compared with conventional methods (such as electrocautery or suturing). The remaining 36% of the studies evaluated the use of Floseal® compared with other haemostatic agents, such as Surgicel®, Gelfoam®, and Hemostase®. FloSeal® has been demonstrated to be an efficacious method in surgical procedures to reduce the time to achieve haemostasis, the frequency of intra- and postoperative bleeding, and the length of hospital stay, among other primary outcomes, resulting in less consumption of health resources. CONCLUSIONS: The majority of the selected studies confirmed that Floseal® showed improvements over other haemostatic agents in achieving haemostasis and reducing blood loss.
Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Esponja de Gelatina Absorvível/uso terapêutico , Hemostasia Cirúrgica/métodos , Hemostáticos/uso terapêutico , Redução de Custos , Esponja de Gelatina Absorvível/economia , Hemostáticos/economia , HumanosRESUMO
PURPOSE: To evaluate the efficacy and cost-effectiveness of FloSeal(®) hemostatic matrix in preventing lymphocele development after pelvic lymphadenectomy (PLA). MATERIALS AND METHODS: This was a single-center, matched comparison of lymphadenectomies in laparoscopic and robot-assisted extraperitoneal radical prostatectomy (ERP) performed with and without FloSeal between January 2008 and October 2009. FloSeal was applied topically in the lymphadenectomy zone immediately after node resection. Cost analysis for lymphocele treatment was performed. RESULTS: A total of 142 patients underwent PLA with ERP (32 with FloSeal, 110 without FloSeal). The mean number of lymph nodes removed was 6.5±4.5 (range 2-20). Median prostate-specific antigen concentration was 8.5 ng/mL (range 1.5-24 ng/mL). There was one (3.1%) symptomatic lymphocele in the FloSeal group compared with 16 (14.5%) in the non-FloSeal group. The median number of lymph nodes removed was 8 (range 5-20) in the FloSeal group and seven (range 3-25) in the non-FloSeal group. The only lymphocele in the FloSeal group was treated with percutaneous drainage alone. In the non-FloSeal group, six symptomatic lymphoceles were managed conservatively-four with percutaneous puncture and six with fenestration after percutaneous drainage. The mean cost per patient of treating symptomatic lymphoceles was 327 ($455) in the FloSeal group (total costs 10,481 [$14,559]) vs 553 ($769) (total costs 60,870 [$84,551]) in the non-FloSeal group. CONCLUSIONS: These preliminary data suggest that the use of FloSeal after lymphadenectomy can reduce the number of symptomatic lymphoceles and is cost-effective.
Assuntos
Esponja de Gelatina Absorvível/farmacologia , Laparoscopia , Excisão de Linfonodo/efeitos adversos , Linfocele/epidemiologia , Linfocele/etiologia , Prostatectomia/efeitos adversos , Robótica , Esponja de Gelatina Absorvível/economia , Humanos , Incidência , Laparoscopia/economia , Excisão de Linfonodo/economia , Masculino , Pessoa de Meia-Idade , Peritônio/efeitos dos fármacos , Peritônio/cirurgia , Prostatectomia/economia , Estudos Retrospectivos , Robótica/economiaRESUMO
OBJECTIVES: To evaluate the efficacy of Floseal as a hemostatic sealant compared to traditional electrocautery hemostasis after cold knife adenotonsillectomy. STUDY DESIGN: Prospective, randomized, controlled trial of 68 consecutive patients undergoing cold steel adenotonsillectomy. Patients were randomized to receive either Floseal (FS) or electrocautery (EC) for hemostasis. RESULTS: FS patients had shorter operative times than EC patients (16 min vs 31.2 min, P < 0.0001) and less blood loss (49.2 mL vs 70.8 mL, P < 0.05). Four EC patients were crossed over to Floseal when adequate hemostasis could not be achieved in the adenoid bed. No Floseal patients were crossed over. FS patients had significantly less pain on postoperative days two through 11 (P < 0.05) and less use of narcotic pain medications over the first 10 postoperative days (P < 0.05). FS patients also had a faster return to regular diet (5.5 days vs 7.9 days, P < 0.01) and activity (5.3 days vs 7.8 days, P < 0.01) as compared to the EC patients. There were no significant complications in either group. CONCLUSIONS: Floseal is safe and efficacious, and decreases postoperative morbidity as compared to electrocautery hemostasis after cold steel adenotonsillectomy. SIGNIFICANCE: This study demonstrates the safety and efficacy of Floseal as a hemostatic method in children undergoing adenotonsillectomy.
Assuntos
Adenoidectomia/efeitos adversos , Perda Sanguínea Cirúrgica/prevenção & controle , Esponja de Gelatina Absorvível/uso terapêutico , Hemostasia Cirúrgica/métodos , Hemostáticos/uso terapêutico , Tonsilectomia/efeitos adversos , Adolescente , Criança , Pré-Escolar , Análise Custo-Benefício , Feminino , Esponja de Gelatina Absorvível/economia , Hemostasia Cirúrgica/economia , Hemostáticos/economia , Humanos , Masculino , Doenças Faríngeas/cirurgia , Estudos Prospectivos , Recuperação de Função Fisiológica , Resultado do TratamentoRESUMO
PROBLEM ADDRESSED: Floseal is a novel matrix hemostatic sealant composed of collagen-derived particles and topical bovine-derived thrombin. It is applied as a high-viscosity gel for hemostasis and has been clinically proven to control bleeding. This study is a prospective, randomized, controlled clinical trial of Floseal sealant compared to traditional suction cautery hemostasis in children undergoing adenoidectomy. METHODS AND MEASURES: Seventy patients (mean age 7.0 yrs, 45.7% male) with obstructive sleep apnea underwent traditional cold steel adenoidectomy with an adenoid curette and were then randomized to receive the hemostatic sealant (Floseal) or cautery to obtain hemostasis. Patients were crossed over to the other hemostatic technique if hemostasis was not achieved after more than 100 mL of blood loss or 15 minutes elapsed time. Objective data collected included time to hemostasis and blood loss during hemostasis. Visual analog scales (VAS) were used to record subjective data by the operating surgeon including bleeding following adenoid pack removal (0 = none, 3 = brisk) and ease of operation (1 = extremely easy, 6 = extremely difficult). Parents recorded diet on a journal and were contacted by phone at postoperative day 7 and questioned with regard to return to regular diet and use of narcotics. RESULTS: Compared to patients in the cautery group (n = 35), Floseal patients (n = 35) had significantly shorter times to hemostasis (0.6 +/- 1.3 minutes vs 9.5 +/- 5.4 minutes [mean +/- SD], P < 0.001), less blood loss (2.5 +/- 9.2 mL vs 29.4 +/- 27.1 mL, P < 0.001), less subjective bleeding (0.0 +/- 0.6 vs 2.0 +/- 0.7, [median 4-point VAS +/- SD], P < 0.001), and subjectively easier operations (2.6 +/- 1.0 vs 5.2 +/- 1.0 [mean 6-point VAS +/- SD], P < 0.001). Furthermore, Floseal patients returned to regular diet earlier (2.7 +/- 0.7 vs 4.1 +/- 0.5 days [mean +/- SD], P < 0.001) and had less use of narcotics at 7 days postoperatively (40% vs 69%, P < 0.05). Lastly, three patients in the cautery group were crossed over to the Floseal group, but no Floseal subjects were crossed over to the cautery group. The retail cost of Floseal is US 85 dollars. Operating room costs are estimated at US 12 dollars/minute. Reducing the operative length by 8.9 minutes on average produces a cost savings of US 106.80 dollars per operation. There were no complications in either experimental group including postoperative hemorrhage, hospitalization, blood transfusion, or aspiration. CONCLUSIONS: Floseal matrix hemostatic sealant is a safe, efficacious, easy, and cost-effective technique for obtaining hemostasis in children undergoing adenoidectomy. Limitations of the study include the fact that it is nonblinded, which does allow for some bias in the subjective data recorded. However, utilizing 4 different operating surgeons, 3 of whom were not affiliated with the study, minimized this. CLINICAL SIGNIFICANCE OF STUDY: This study demonstrates the safety and efficacy of a novel hemostatic sealant in children undergoing adenoidectomy. Floseal matrix hemostatic sealant can be used as a first-line hemostatic agent, and it is a good tool in the armamentarium of otolaryngologists who encounter significant bleeding following adenoidectomy.
Assuntos
Adenoidectomia/métodos , Esponja de Gelatina Absorvível/uso terapêutico , Hemostasia Cirúrgica/instrumentação , Hemostáticos/uso terapêutico , Adenoidectomia/economia , Adolescente , Perda Sanguínea Cirúrgica/prevenção & controle , Criança , Pré-Escolar , Análise Custo-Benefício , Eletrocoagulação/economia , Eletrocoagulação/métodos , Feminino , Esponja de Gelatina Absorvível/economia , Hemostasia Cirúrgica/economia , Hemostáticos/economia , Humanos , Lactente , Masculino , Estudos Prospectivos , Apneia Obstrutiva do Sono/cirurgia , Fatores de Tempo , Resultado do TratamentoRESUMO
Saving the physicians time is very desirable in rendering first-rate dermatological service at lower cost. The aim is to reduce surgical instrumentation during skin biopsy procedures and follow-up visits. A combined instrument is used to obtain skin biopsies from 100 patients, and gelatin sponge plugs are used in hemostasis and to assist healing of the biopsy wound site. Skin biopsy samples are obtained simply and with ease, and, as the tissue sample is handled minimally, it appears to be more intact and less distorted in comparison to the usual procedure. Skin biopsy samples can be obtained with the combined instrument in a more cost-effective manner with savings of the physician's time and less instrumentation.