Cost-benefit analysis of outcomes from the use of fibrin sealant for fixation of skin grafts in small-size burns compared to staples as historical controls: a retrospective review.

INTRODUCTION: Historically, split-thickness skin grafts have been fixed onto the recipient site by suture and/or staples. Fibrin sealants have become available for the fixation in the past 10 years. Fibrin sealants have been shown to be at least as effective as staples, and recent reports show them to cause less pain. However, the product is much more expensive than traditional suture and/or staple fixation. The cost-benefit ratio of sealant has not yet been proven. METHODS: A review of charts for 202 consecutive patients was undertaken for patients with burns that were less than 10% total body surface area (TBSA) that underwent excision and grafting using fibrin sealant at the regional burn center. A historical control comprising 48 consecutive patients with burns that were less than 10% TBSA that underwent excision and grafting using staples as the only means of fixation was used for comparison. Demographics (such as age, weight, and sex), personal history of tobacco use, previous diagnosis of diabetes, type and depth of burn, TBSA, area of grafting, graft and donor locations, mesh type, rate of hematomas, rate of graft loss, rate of complete closure at 1 month, and time to discharge after surgery were recorded for each patient in both cohorts. The data were compared and statistical analysis performed for graft loss complications and number of days until the patient could be discharged home with outpatient wound care. RESULTS: Use of fibrin sealants has resulted in statistically significant lower rates of loss of graft at our institution. Additionally, a decrease in the number of days until discharge to outpatient wound care of nearly 2 days produced a lower cost of care in patients with less than 10% TBSA undergoing excision and grafting. CONCLUSIONS: The use of fibrin sealants allows for fewer graft loss complications and earlier discharge in patients who have burns that are less than 10% TBSA. This decrease in hospital days results in savings, although this difference is not statistically significant.

Surgical Treatment of Pressure Ulcers with a Fibrin Sealant in Patients with Spinal Cord Injury: A Cost-Consequence Analysis.

BACKGROUND: A comparative study was performed to evaluate the effectiveness and costs of a fibrin sealant (Tissucol Duo [known as Tisseel in the United States], Baxter International, Deerfield, Illinois) to improve postoperative outcomes in patients with spinal cord injury undergoing surgical treatment for pressure ulcers (PrUs). METHODS: Between January and June 2011, 27 patients underwent surgical treatment for PrUs with the direct application of Tissucol Duo sprayed before closure. The costs and outcomes obtained in this cohort were compared with those obtained in a previous retrospective study where 71 patients underwent conventional surgery. RESULTS: Lower rates of hematoma-seroma were observed in the study group (3.7% vs 33.8%; P < .05). Drain removal occurred earlier (10 vs 15 days; P < .05), and the average drain volume was also lower (155 vs 360 mL; P < .05) for this group. The mean length of hospital stay was significantly lower in the study group and was the main contributing factor to the overall costs. CONCLUSIONS: The application of Tissucol Duo during surgical treatment of PrUs in patients with spinal cord injury has been shown to be effective in reducing postoperative complications and in shortening the duration of the hospital stay with a consequent savings in costs.

Use of tissue glues in endoscopic pituitary surgery: a cost comparison.

BACKGROUND: Post-operative cerebrospinal fluid (CSF) leaks are a common complication of endoscopic pituitary surgery and account for a significant proportion of hospital costs associated with this procedure. Tisseel® is a tissue glue commonly used as an adjunct in dural repair but is not optimal for this purpose. DuraSeal® has several properties advantageous for dural repair but is not widely accepted in Canada partly due to its increased cost. OBJECTIVE: A cost analysis of DuraSeal® versus Tisseel® in endoscopic pituitary surgery. METHODS: A cost analysis was performed based on typical endoscopic pituitary surgery cases performed at our tertiary care institution. Operating room, hospital admission, and surgical sealant costs were obtained directly while estimates of patient recovery time and post-operative CSF leak rates were based on consensus values reported in the literature. Outcomes were reported for various possible clinical scenarios of sealant use. RESULTS: In a model where surgical sealant is employed only in high-risk cases, use of DuraSeal® allows for a yearly cost savings of at least $4486.72. If surgical sealant is used in all cases, regular use of DuraSeal® versus Tisseel® either marginally reduces yearly costs or increases them by a maximum of $7619.25, depending on the case volume and estimated post-operative CSF leak rate. CONCLUSION: In most clinical scenarios, use of DuraSeal® in endoscopic pituitary surgery may reduce overall yearly hospital costs compared to Tisseel®.

Analysing uncertainty around costs of innovative medical technologies: the case of fibrin sealant (QUIXIL) for total knee replacement.

This paper presents a relatively simple cost model comparing the costs of using a commercial fibrin sealant (QUIXIL) in addition to conventional haemostatic treatment vs. conventional treatment alone in total knee replacement (TKR) surgery, and demonstrates and discusses how one- and two-way sensitivity analyses can inform decisions regarding an innovative medical technology, for which there is limited evidence on economic parameters. The model synthesises data from various sources and assesses the proportion of individuals likely to need blood transfusion, the resource use after TKR and transfusion-related adverse events. Whether using fibrin sealant is cost saving strongly depends on the amount used, the achieved reduction in hospital length of stay (LOS) and price of QUIXIL. If a 10-ml dose of fibrin sealant is required to achieve the effects as described in the published trials, its use adds cost, but if 25% or more of patients are treated with a 5-ml dose, its use becomes cost saving for the NHS. The sensitivity analyses provide clear guidance regarding parameters for additional data collection; design of future trials; and product pricing in relation to its effectiveness, and are likely to be preferred over more sophisticated approaches to inform medical device decision-making, particularly at the local level.

Efficacy of fibrin sealant in thyroid surgery. Is drainage still necessary?

INTRODUCTION: The routinely use of drains in thyroid surgery is a traditional and well-defined method, even if there is no clear evidence of significant improvement in patients outcomes. Aim of our study is to define the feasibility, safety and cost- effectiveness of fibrin sealant in total thyroidectomy in order to overcome the use of drains. MATERIALS AND METHODS: We enrolled 262 patients (45 men and 217 women, mean age 54.7 yrs) undergone total thyroidectomy in University Hospital of Palermo (Italy), between July 2015 and October 2017. We randomized patients into group A (drain) and group B (no drain, fibrin sealant application). RESULTS: We registered statistical difference between the two groups in mean operative time, visual analogue scale of pain, post-operative stay, incidence of seromas and/or deep and superficial hematomas, re-operation and wound infection (reduced in the fibrin sealant group). No significant difference have been found in intraoperative blood loss, postoperative cough, post-operative use of analgesic and in incidence of hypoparathyroidism or recurrent palsy. CONCLUSIONS: Our study demonstrates that there is no evidence that the use of suction drains improves patients outcome and that routinely use of fibrin sealant can be advocated in thyroid surgery as an adjunct to a good surgical procedure. KEY WORDS: Complication, Drainage, Fibrin Sealant, Thyroidectomy.

Fibrin sealant does not decrease seroma output or time to drain removal following inguino-femoral lymph node dissection in melanoma patients: a randomized controlled trial (NCT00506311).

BACKGROUND: This study assessed the impact of closed suction drains and evaluated whether the intraoperative use of a fibrin sealant decreased time to drain removal and wound complications in melanoma patients undergoing inguino-femoral lymph node dissection. METHODS: A pilot study (n = 18) assessed the impact of a closed suction drain following inguino-femoral lymph node dissection. A single-institution, prospective trial was then performed in which patients were randomized to a group that received intraoperative application of a fibrin sealant following inguino-femoral lymph node dissection or to a control group that did not receive sealant. RESULTS: The majority of the patients enrolled felt the drains caused moderate or severe discomfort and difficulties with activities of daily living. Thirty patients were then randomized; the median time to drain removal in the control group (n = 14) was 30 days (range, 13-74) compared to 29 days (range, 11-45) in the fibrin sealant group (n = 16; P = 0.6). Major and minor complications were similar in the two groups. CONCLUSION: Postoperative closed suction drains were associated with major patient inconvenience. Applying a fibrin sealant at the time of inguino-femoral lymph node dissection in melanoma patients did not reduce the time to drain removal or postoperative morbidity. Alternative strategies are needed.

Laparoscopic repair of inguinal hernias using an intraperitoneal onlay mesh technique and a Parietex composite mesh fixed with fibrin glue (Tissucol). Personal technique and preliminary results.

INTRODUCTION: Laparoscopic repair of inguinal hernias is usually achieved by totally extraperitoneal (TEP) or transabdominal preperitoneal (TAPP) techniques. The intraperitoneal onlay mesh (IPOM) could be an interesting alternative as it is much easier to perform and faster to execute. This technique is subject to correct selection of indications and to demonstration of its safety. MATERIALS AND METHODS: From January 2003 to January 2006 we performed 61 laparoscopic hernia procedures on 60 selected patients (60 males with a mean age of 60 and mean weight of 76 kg) with an IPOM technique combining the Parietex composite mesh (12 cm circular model) and a fibrin glue (Tissucol) for its fixation. The glue was diluted to increase fixation time and applied to the mesh prior to positioning on the hernia defect. RESULTS: Mean operative time was 10 minutes. Mean hernia diameter was 2.5 cm (+/- 0.8 cm). 10 hernias were direct, 51 were indirect and 10 out of 61 were recurrent. We did not convert any of the laparoscopic procedures. Mean hospital stay was one day; mean recovery time for working and general physical activities was five days. Patients were checked after one week, 1-3-6 months and 1-2 years. Average follow up time was 23.7 months. 1.6 % of patients showed short-term complications: one trocar site haematoma. No additional complications were reported; particularly, we had no recurrence, no seroma, no mesh migration, and no bowel obstruction or fistula. CONCLUSION: Results of this study show intraperitoneal (IP) tolerance to this kind of mesh and the safety of its fixation with Tissucol. The absence of recurrence and complications could be a good reason to extend the indication of IPOM hernia repair. However, these preliminary results should be confirmed by longer follow-up.

Clinical application of topical sealants in liver surgery: does it work?

Hepatic resections are considered as a standard intervention in abdominal surgery. However there is still a remarkable complication rate. Despite all recent developments in surgical techniques during liver surgery, blood loss is still one of the main causes for postoperative morbidity and mortality. In addition to patient-dependent factors, aspects of the surgical technique play a major role, in particular with regard to the occurrence of peri-operative bleeding, fluid accumulation and bile leakage. Nowadays, the use of topical sealants is often recommended as an additional tool to decrease postoperative bleeding and bile fistula. Fibrin sealants are able not only to enhance clot formation and wound healing, but possibly work as a sealing device for the small biliary branches. In this overview we will try to evaluate the efficacy in terms of time to complete haemostasis, the need for blood transfusions and the incidence of bile leakage according to recent trials. Furthermore the clinical benefit for the liver surgery patient will be discussed.

Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair: a study with a 40-month prospective follow-up period.

BACKGROUND: Anchoring the mesh in laparoscopic totally extraperitoneal groin hernia repair (TEP) with human fibrin glue has theoretical advantages. However, these have been supported and reported previously only in animal studies. Before the initiation of large patient trials, the authors wanted to confirm the feasibility, assess the costs, and rule out any flagrant short- and long-term adverse effects of fibrin glue usage in a small series of patients. METHODS: Nine consecutive TEP repairs with fibrin glue mesh fixation were performed. The perioperative and postoperative outcomes at 1, 16, and 40 months were compared with those for a control group of 96 stapled repairs. RESULTS: Gluing was easy and is less expensive than stapling. No fibrin glue-related adverse effects were found. The overall outcome was similar to that for stapled repairs, with no indication that the glued repairs were inferior. CONCLUSIONS: Fibrin glue seems to be a reasonable, feasible, and maybe even competitive alternative to the standard tissue-penetrating mesh fixation. The results of this study justify launching larger trials.

Drug targets in colonoscopic polypectomy: biological sealants with special reference to fibrin-glue (tissucol).

The increasing outpatient use of colonoscopy in the diagnostic study and prophylaxis of colon diseases has allowed early identification of polypoid neoformations, thus indicating their increased incidence during the asymptomatic phase. In this respect, the application of biological sealants immediately before the polypectomy has represented a novel therapeutic strategy in the treatment of these preneoplastic lesions. The injection of biological sealants with needle under the polyp peduncle or sub-mucosa has demonstrated a protective action on the electrocoagulated area, an anti-haemorrhagic effect owing to the strengthened seal of the eschar that is formed, and a facilitated tissue regeneration, respectively. The author report his experience acquired over the past five years with regard to the use of biological sealant in colonoscopic polypectomy and conclude that biological sealants, a human fibrin glue, which utilises components of the human plasma, may allow a more generous removal of neoformations, the absence of post-polypectomy complications and, consequently, the dramatic reduction of time of patient's admission in the hospital. In fact, all patients were discharged after two hours from polypectomy, thus implying a better quality of life for patients, in the absence of post-operative complications and a reduction of non-medical costs.

Influence of fibrin glue on seroma formation after breast surgery.

BACKGROUND: This study was designed to determine the effectiveness of Hemaseel APR fibrin sealant versus conventional drain placement in the prevention of seromas after breast procedures. METHODS: A prospective, randomized, controlled study of subjects who were randomized into control (drain) and experimental (fibrin) groups was conducted. RESULTS: Analysis of 82 patients showed similarly matched groups. Seroma formation rate was 45.5% in the control group and 36.8% in the fibrin glue group (P = 0.43). The rate of wound complications was similar. Aspirate volumes were significantly greater in the fibrin glue group. Drain placement saved patients >366 US dollars over fibrin glue. CONCLUSIONS: Although use of fibrin sealant resulted in a nonsignificant decrease in seroma formation rate compared with that of drain placement, the higher cost involved, cumbersome technique, and higher aspirate volumes tend to indicate that there is no advantage to using fibrin glue over drain placement with the technique described.

Fibrin sealant in surgery of patients with a hemorrhagic diathesis.

The utilization of fibrin sealants in patients with hemostatic disorders has hitherto been very limited. Our experiences from 40 major and 8 minor surgical procedures, 10 circumcisions and 118 tooth extractions in 106 patients with hemophilia A, B or von Willebrand's disease, almost exclusively of the severe form, respectively, demonstrate the benefits regarding reduction of blood loss and requirements for systemic replacement therapy. The literature on the use of fibrin sealants in this group of patients, which mainly concerns dental procedures, is reviewed and compared with our data. The importance of the composition of the glue is also discussed in detail.

Does fibrin glue sealant decrease the rate of pancreatic fistula after pancreaticoduodenectomy? Results of a prospective randomized trial.

Despite substantial improvements in perioperative mortality, complications, and specifically the development of a pancreatic fistula, remain a common occurrence after pancreaticoduodenectomy. It was the objective of this study to evaluate the role of fibrin glue sealant as an adjunct to decrease the rate of pancreatic fistula after pancreaticoduodenectomy. One hundred twenty-five patients were randomized after pancreaticoduodenal resection only if, in the opinion of the surgeon, the pancreaticojejunal anastomosis was at high risk for development of a pancreatic anastomotic leak. After completion of the pancreaticojejunal anastomosis, the patients were randomized to topical application of fibrin glue sealant to the surface of the anastomosis or no such application. The primary postoperative end points in this study were pancreatic fistula, total complications, death, and length of hospital stay. A total of 59 patients were randomized to the fibrin glue arm, whereas 66 patients were randomized to the control arm and did not receive fibrin glue application. The pancreatic fistula rate in the fibrin glue arm of the study was 26% vs. 30% in the control group (p = not significant [NS]). The mean length of postoperative stay for all patients randomized was similar (fibrin glue = 12.2 days, control = 13.6 days) and the mean length of stay for patients in whom pancreatic fistula developed was also not different (fibrin glue = 18.9 days, control = 21.7 days). There were no differences with respect to total complications or specific complications such as postoperative bleeding, infection, or delayed gastric emptying. These data demonstrate that the topical application of fibrin glue sealant to the surface of the pancreatic anastomosis in this patient population undergoing high-risk pancreaticojejunal anastomosis did not reduce the incidence of pancreatic fistula or total complications after pancreaticodudodenectomy. There seems to be no benefit regarding the use of this substance in this setting.

Use of Tisseel fibrin sealant in neurosurgical procedures: incidence of cerebrospinal fluid leaks and cost-benefit analysis in a retrospective study.

OBJECTIVE: To determine the clinical efficacy and cost effectiveness of using the fibrin sealant (FS) Tisseel (Baxter Healthcare Corp., Deerfield, IL) for patients undergoing anterior cranial base, infratemporal, and retromastoid surgical procedures. METHODS: A retrospective review was performed, comparing two matched populations of patients who underwent surgical procedures using anterior cranial, infratemporal, or retromastoid approaches to intracranial pathological lesions. The incidences of cerebrospinal fluid (CSF) leaks in matched groups treated with the FS Tisseel or treated without FS were compared. The costs of Tisseel use were examined in comparison with the costs of postoperative management of CSF leaks and/or tension pneumocranium with spinal drainage and occasionally surgical reexploration, when lumbar drainage failed. RESULTS: Patients who received the FS Tisseel exhibited no detectable postoperative CSF leaks or tension pneumocranium. Patients who did not receive Tisseel demonstrated 4 to 16% incidences of postoperative leaks, depending on the surgical approach used. The costs of treating those leaks far exceeded the costs of using Tisseel, even if it were used indiscriminately for all patients. CONCLUSION: This retrospective review indicates that the FS Tisseel reduces the incidence of postoperative CSF leaks and tension pneumocranium while reducing overall management costs. Further prospective study is needed to determine which patients can benefit most from FS use.

Cost evaluation of two methods of post tooth extraction hemostasis in patients on anticoagulant therapy.

The classical management of patients on oral anticoagulant therapy included hospitalisation, cessation of the anticoagulant agent, and extraction of teeth when the prothrombine levels rise. This method was substituted in the High Risk Dental Clinic at Barzilai Medical Center in Ashkelon by use of a tissue sealant (Tisseel) which does not need hospitalisation nor cessation of the anticoagulant therapy. In comparing the last 23 sessions employing the former method to the first 23 sessions using the new method there were significant differences in the cost effectiveness for the health system, provider, insurer and patient. Despite the fact that from the health system point of view the new method is much more cost effective, there is no financial incentive for the provider (hospital) nor awareness on the part of the insurer (General Sick Fund) to embrace it and 'market' it.

Tissucol application in dermolipectomy and incisional hernia repair.

Biological adhesives have a lot of applications in surgical procedures. Here we present a prospective study with the aim of analyzing results of the application of Tissucol between the muscle layers and subcutaneous tissue after incisional hernia repair with polypropylene mesh and associated dermolipectomy. We assess clinical and technical parameters, local morbidity, and hospital stay. Fifty-six patients were divided into two groups. Patients with whom we used fibrin glue were older, with more obesity (P < 0.005) with associated diseases, and their incisional hernias were larger and more complicated to repair. Patients in the Tissucol group developed less local morbidity (hematomas or abscesses; P < 0.01), had a shorter mean hospital stay (P < 0.01), and required less wound care. The use of Tissucol improves the results of surgical repair of large abdominal incisional hernias repaired by mesh placement and dermolipectomy, and it decreases global morbidity and hospital stay are reduced.

[Endoscopic treatment of intestinal anastomotic leakage in low anterior resection of the rectum by using fibrin adhesive. Our experience]. / Trattamento endoscopico delle deiscenze anastomotiche nelle resezioni anteriori del retto mediante applicazione di colla di fibrina. Nostra esperienza.

BACKGROUND: Personal experience about treatment of anastomotic leakage in low anterior resection of the rectum by using human fibrin adhesive "Tissucol" is reported. METHODS: Eight cases of anastomotic leakage treated with using human fibrin adhesive "Tissucol", are analyzed in a retrospective study. Patients had three/six months-one year follow up. Treatment with human fibrin adhesive "Tissucol" was performed in our Endoscopic ambulatory. Six cases had either an immediate resolution or an ambulatorial follow-up; in 2 cases only, general complications forced to a prolonged hospital stay. The study concerns 58 patients subjected to low anterior resection of the rectum and endoscopic treatment of 8/58 patients with anastomotic leakage. Fistulas were sealed with human fibrin adhesive "Tissucol" by using flexible endoscope. Anastomotic leakage identification leakage was made and low anterior resection of the rectum and sealing with human fibrin adhesive "Tissucol" were performed. RESULTS: Complete sealing of fistula and rectum patent. CONCLUSIONS: The excellent results obtained with this non invasive and fast treatment, easily practicable even in ambulatorial regimen, lead the authors to consider it effective and as first-choice treatment of this dangerous complication. The cost/benefit ratio is favorable if compared with the long hospital stay required for other treatments, which also present loaded high morbidity and mortality.

Intrasac fibrin glue injection after platinum coils placement: the efficacy of a simple intraoperative procedure in preventing type II endoleak after endovascular aneurysm repair.

OBJECTIVES: To verify in our experience if fibrin glue injection into the aneurysm sac, made at the end of endovascular aneurysm repair (EVAR), can reduce type II endoleak rates. METHODS: Between January 2005 and February 2008, 38 patients underwent EVAR for an unruptured abdominal aortic aneurysm. The first 20 consecutive patients (Group A) had standard EVAR while the last 18 patients (Group B) had EVAR with fibrin glue injection into the sac, regardless of type II endoleak's presence. RESULTS: There was no statistically significant difference between the two groups concerning the surgical time and the time of X-ray exposure (P=0.30 and 0.54, respectively). Type II endoleak rate was significantly higher in Group A compared to Group B (6 cases, 30% vs. 1 case, 5.5%, respectively, P=0.05). Primary short-term clinical success was 95% and 100%, respectively. At 12 months, selective lumbar embolization was performed in two patients in Group A and in one patient in Group B. Patients in Group A had less computed tomography (CT) studies than patients in Group B (2.0 vs. 1.2, respectively, P=0.024). CONCLUSIONS: Fibrin glue injection is a safe procedure and seems to reduce type II endoleak rates. Patients who received this procedure had fewer CT examinations, with reduced health-care costs.

Use of tissue sealant for day surgery parotidectomy.

OBJECTIVES: To evaluate the use of tissue sealant in facilitating day surgery parotidectomy without the use of surgical drains and to consider the potential economic benefit using this technique. STUDY DESIGN AND SETTING: Prospective cohort study of 21 patients undergoing parotidectomy for nonmalignant disease in a university hospital. Surgery as a day procedure without the use of surgical drains was planned. The costs associated with parotidectomy, including the use of tissue sealant and its delivery system, versus in-patient admission with a drain were calculated and compared. METHODS AND OUTCOME MEASURES: Parotidectomy was undertaken by one surgeon. Prior to wound closure, the skin flap and wound bed were approximated using Tisseel tissue sealant (Baxter Corp., Mississauga, ON). Data regarding the costs of the tissue sealant, the delivery system, and hospital in-patient stay were obtained to enable an economic comparison. Patients were followed to assess surgical outcome and document any complications. RESULTS: There were no major surgical complications. One patient required admission for control of postoperative nausea. None of the patients felt that discharge had been premature. The estimated cost advantage of this technique applied to institutions in Canada was $1,775 per case. CONCLUSIONS: Parotidectomy can be undertaken safely in a day surgery setting without the need for surgical drains. The increased cost associated with the use of tissue sealant compared with surgical drains is greatly overshadowed by the economic advantage of undertaking day surgery. There is a significant potential cost saving to the health care system.