Use Of TachoSil Research Articles

Validation of Efficacy and Safety of TachoSil ® Tissue Sealant for Vessel Transposition in Microvascular Decompression.

Use of TachoSil ® as the transposition material of microvascular decompression (MVD) for hemifacial spasm (HFS) and trigeminal neuralgia (TN) is easy and safe to perform, but the efficacy and safety of this technique are unknown. This study attempted to validate the efficacy and safety of TachoSil ® as a transposition material of MVD. A retrospective study of the surgical results and complications of 63 patients (35 HFS and 28 TN) treated by the TachoSil ® technique between January 2011 and December 2021 was conducted. The efficacy of the treatment was evaluated by Kaplan-Meier survival analysis. Magnetic resonance imaging follow-up study was performed to detect any adverse events including a mass formation. The rate of complete disappearance of HFS was 91.4% at 1 year and estimated to be 85.7% after a 10-year follow-up. The rate of no pain without medication for TN was 85.4% at 1 year and estimated to be 69.0% after a 9-year follow-up. These surgical results are comparable with those previously reported. Flaking of TachoSil ® releasing the offending artery was only recognized in one case (1.6%). Therefore, TachoSil ® can be considered as an effective transposition material for MVD. TachoSil ® did not increase the rate of acute and subacute adverse events such as inflammation and delayed facial palsy. Magnetic resonance imaging follow-up identified no abnormalities including mass that suggested granuloma formation. The efficacy of the TachoSil ® technique for HFS and TN and the reliability of TachoSil ® as an adhesive material in MVD were verified. No adverse events associated with TachoSil ® use in MVD were found. We conclude that the TachoSil ® technique has relatively long efficacy and safety for MVD.

Collagen-bound fibrin sealant (TachoSil®) for dural closure in cranial surgery: single-centre comparative cohort study and systematic review of the literature

Cerebrospinal fluid (CSF) leakage is a well-known complication of craniotomies and there are several dural closure techniques. One commonly used commercial product as adjunct for dural closure is the collagen-bound fibrin sealant TachoSil®. We analysed whether the addition of TachoSil has beneficial effects on postoperative complications and outcomes. Our prospective, institutional database was retrospectively queried, and 662 patients undergoing craniotomy were included. Three hundred fifty-two were treated with dural suture alone, and in 310, TachoSil was added after primary suture. Our primary endpoint was the rate of postoperative complications associated with CSF leakage. Secondary endpoints included functional, disability and neurological outcome. Systematic review according to PRISMA guidelines was performed to identify studies comparing primary dural closure with and without additional sealants. Postoperative complications associated with CSF leakage occurred in 24 (7.74%) and 28 (7.95%) procedures with or without TachoSil, respectively (p = 0.960). Multivariate analysis confirmed no significant differences in complication rate between the two groups (aOR 0.97, 95% CI 0.53–1.80, p = 0.930). There were no significant disparities in postoperative functional, disability or neurological scores. The systematic review identified 661 and included 8 studies in the qualitative synthesis. None showed a significant superiority of additional sealants over standard technique regarding complications, rates of revision surgery or outcome. According to our findings, we summarize that routinary use of TachoSil and similar products as adjuncts to primary dural sutures after intracranial surgical procedures is safe but without clear advantage in complication avoidance or outcome. Future studies should investigate whether their use is beneficial in high-risk settings.

Endoscopic transsphenoidal surgery reconstruction using the fibrin sealant patch Tachosil®

Introduction The incidence of CSF leak following endoscopic transsphenoidal surgery remains the most important measure in the success of any repair. The nasoseptal flap (NSF) has played a pivotal role in reconstructing defects. However, morbidity associated with the NSF includes bleeding, septal injury, altered smell and crusting. Tachosil® is an absorbable fibrin sealant patch that promotes haemostasis and wound healing. The purpose of this study was to evaluate the effectiveness of Tachosil® to repair intraoperative defects during an endoscopic transsphenoidal approach. Materials and methods All patients who underwent an endoscopic transsphenoidal approach with the use of Tachosil® at the Queen Elizabeth Hospital Birmingham, between January 2013 and June 2020 were retrospectively analysed. Tachosil® was used as an overlay patch over of the bony defect, in a multi-layered repair depending on the defect and grade of CSF leak. The primary outcome measure was post-operative CSF leak. Results A total of 52 primary procedures where Tachosil® was used as the overlay were analysed. There were 23 (44.2%) intraoperative CSF leaks. The overall post-operative CSF leak rate was 7.8% (n = 4), with all cases having had a Tachosil® overlay reconstruction with no NSF. A formal NSF was harvested in only five cases alongside the Tachosil® patch, where a grade 2 or more leak was identified at the time of the primary procedure, none of which developed a post-operative leak. No patient had any post-operative adverse outcomes that were attributed to Tachosil®. Conclusions We believe this to be the largest case series evaluating the endoscopic use of Tachosil® in skull base reconstruction. Our data show that in endoscopic transsphenoidal approach, Tachosil® may be used safely in a multi-layered approach as an effective alternative to the NSF in low flow CSF leak cases, or alongside a NSF in higher flow leaks.

The use of collagen fleece (TachoSil) as grafting material in the surgical treatment of Peyronie's disease. A comprehensive narrative review.

Grafting for the treatment of Peyronie's disease (PD) can be performed with autologous grafts, allografts, xenografts and synthetic grafts, with all available materials presenting their own characteristics. Still, there is a current arising interest in the use of collagen fleece (TachoSil) as grafting material. We generated an extensive literature review, aiming to assess the use of TachoSil in the treatment of PD. TachoSil is currently indicated in men with PD and preserved erectile function for defect closure after partial plaque excision or incision. In addition, it is indicated for residual curvature correction during penile prosthesis implantation (PPI) in patients with PD and severe erectile dysfunction. Our literature search identified 12 studies evaluating the role of TachoSil for PD surgical treatment. We presented the surgical procedure of TachoSil grafting for the treatment of complex penile curvatures with or without simultaneous PPI and summarized the available evidence on the matter. Identified studies suggest that TachoSil is considered highly effective, reliable and safe in patients with PD. Moreover, it displays favorable properties compared to other grafting materials. It should be stressed that, despite some limitations of available data, TachoSil presents key strengths, which include easy application, decreased operative times, no risk of damaging the implant during PPI, preservation or increase in penile length, fewer cases of penile hypoesthesia, low risk of other adverse events, additional hemostatic effects and low cost. Still, randomized trials comparing TachoSil with different grafting materials are necessary to establish its efficacy.

Effectiveness of hemostatic agents in thyroid surgery for the prevention of postoperative bleeding

Postoperative bleeding remains one of the most frequent, but rarely life-threatening complications in thyroid surgery. Although arterial bleeding is the main cause of postoperative hemorrhage, most often no actively bleeding vessel can be found during revision. Therefore, the coagulation technique for larger vessels may play a minor role, and hemostatic agents could be of higher importance. In this descriptive, retrospective study, data of 279 patients with thyroid surgery (total of 414 thyroid lobectomies) were collected. We reviewed the electronic medical record by analyzing the histological, operative, laboratory and discharge reports in regards to postoperative bleeding. Of the 414 operated thyroid lobes, 2.4% (n = 10) bled. 1.4% (n = 6) needed reoperation while the other 1.0% (n = 4) could be treated conservatively. Hemostatic patches were applied 286 (69.1%) times. Of the 128 (30.9%) patch-free operated sides, 4.7% (n = 6) suffered postoperative bleeding. Tachosil® alone was used 211 (51.0%) times and bleeding occurred in 1.4% (n = 3). Without statistical significance (p = 0.08) the use of Tachosil® seems to help preventing postoperative bleeding. The combination with other patches doesn’t appear to be more efficient.

Incision de plaque et greffe de Tachosil chez les patients atteints d’une maladie de Lapeyronie

Surgery is a treatment for correction of penile curvature in Peyronie's disease. Partial plaque excision and grafting is recommended for severe and complex curvature. Patients with stable penile curvature who underwent a partial plaque excision and grafting between January 2017 and April 2018 were retrospectively included. The graft was realized using a self-adhesive collagen fleece (Tachosil®). Penile curvature, penile length and erection score were measured before and after surgery. Twenty-one patients, aged 52,13 (18-70years) were included. The average follow-up after surgery was 8,36months (1-14months). Early complications included two hematomas and one dysuria (Clavien 1). One patient had a penile prosthesis hernia 3 months after surgery, and needed a new surgery (Clavien 3B). Patients stayed at the hospital 1.38 night (1-5) and operating time was 158min (102-249min). Average penile curvature after surgery was 5.88° (0-30°), while it was 82.75° (50-100°) before. Erection score increased from 7.62 (3-10) to 7.86 (4-10). There was no modification of the penile length 11.92cm (11-14.5) after surgery and 12.09cm (10-15cm) before. The use of TachoSil® reduces the operative time, is easy to use and has hemostatic properties at a low cost. However, prospective randomized trial and long terms results are required to confirm our encouraging results. 3.

Could we reduce adhesions to the intra-abdominal mesh in the first week? Experimental study with different methods of fixation.

Adhesion formation is a major problem when a mesh is exposed to intraabodminal viscera, with potential severe complications (bowel occlusion, fistulas or abscesses). New methods for preventing adhesions from a polypropylene mesh placed intra-abdominally or to solve difficult situations, such as when the peritoneum cannot be closed during a TAPP repair for an inguinal hernia, are still being seeked. This study mimics in an animal model a situation that can be found in clinical practice during laparoscopic inguinal hernioplasty. A polypropylene mesh could be exposed to the intra-abdominal cavity even when the peritoneum is closed due to different circumstances, with no options to guarantee the prosthetic material of being exposed to the intrabdominal viscera. Different options have been suggested to solve these situations, being proposed in this study to cover the visceral surface of the mesh with an absorbable sponge containing thrombin, fibrinogen, and clotting factors (Tachosil®, Nycomed, Takeda, Osaka, Japan), to assess its use as a barrier to prevent postoperative adhesion formation. Thirty Wistar white rats (300-450mg) were included in this study as experimental animals, being randomized into three groups (A, B, and C). We performed a bilateral prosthetic repair with conventional polypropylene mesh (2 × 2cm, 82kD). Prosthesis fixation was performed as follows. Group A: absorbable suture; group B: metal staples; group C: metal tackers. A piece of insulating absorbable sponge (Tachosil® 5 × 5cm) was placed to cover the visceral surface of mesh placed at the right side of each animal. After 10days, we performed a gross examination (by laparoscopy and laparotomy), measuring the quantity and the quality of the adhesions. Samples were taken for histopathological analysis. Tachosil®-treated prostheses showed a statistically significant decrease in the quality of the adhesion found (p < 0.05). In addition, a smaller quantity of adhesions was identified in barrier-treated animals, although this lacked statistical significance. The histologic analysis showed no significant differences: more edema with the untreated mesh and increased angiogenesis and a lower degree of necrosis in mesh covered with Tachosil®. The use of Tachosil® as a barrier material led to the absence of strong adhesions as it prevented direct contact between the mesh and the internal organs, preventing major problems associated with strong adhesions.

Sellar Diaphragm Reconstruction with Tachosil During Endoscopic Endonasal Surgery: Technical Note.

This report introduces a new closure technique for the management of intraoperative cerebrospinal fluid (CSF) leakage during endoscopic endonasal surgery. The procedure is based on the combination of a traditional autologous tissue flap with a heterologous fibrin graft (TachoSil). We performed a retrospective analysis on 121 patients with pituitary adenomas treated in our center by the senior neurosurgeon (author V.R.B) in the previous 4 years. Only one patient (0.8%) developed a CSF leakage and no adverse events were found related to the use of TachoSil. Compared with other techniques used previously, sellar diaphragm reconstruction with TachoSil seems to be an effective and inexpensive alternative.

Evolution of the surgical sealing patch TachoSil® in Peyronie's disease reconstructive surgery: technique and contemporary literature review.

The aim of this study is to review the current literature that reports outcomes of Peyronie's disease (PD) reconstructive surgery using the collagen fleece TachoSil® (Baxter, CA, USA), a novel graft that has self-adhesive properties and gained popularity in recent years. A literature review was performed through PubMed between 2013 and 2018 regarding the use of TachoSil® in PD penile reconstructive surgery. Keywords used for the search were: Peyronie's disease, surgical therapy, surgical outcomes, grafting techniques, graft materials, collagen fleece, surgical patch, and TachoSil. Grafting procedures are indicated for men with PD and preserved erectile function. TachoSil® is a novel graft used for defect closure after tunical incision or partial plaque excision. Long-term results of this technique are encouraging and reliable. One major advantage over other grafts is that the TachoSil® does not require suture fixation leading to significantly decreased operative times. Another indication is residual curvature correction by plaque incision and grafting/sealing with TachoSil® during penile prosthesis implantation in patients with PD and severe erectile dysfunction. Besides reduced operative times, the major advantage is that there is no risk of device puncture because of the self-adhesive properties of the TachoSil®. The TachoSil® has emerged as a safe, reliable, and promising graft in PD reconstructive surgery. Until now, this graft has met the expectations as a durable and effective graft, not only for grafting techniques but also for residual curvature correction during penile prosthesis implantation. However, future research is encouraged, preferably within prospective multicenter studies.

Results of TachoSil® associated with fibrin glue as dural sealant in a series of patients with spinal intradural tumors surgery. Technical note with a review of the literature

A major problem of surgery for intradural spinal tumors (IST) is the occurrence in the post-operative period of a cerebrospinal fluid (CSF) leak. To the best of our knowledge, here we report on the largest series of IST patients in whom the TachoSil® associated to fibrin glue was used as dural sealant in this kind of surgery. Moreover, we extensively reviewed the literature reporting the results of TachoSil® in spine surgery. The data of 35 consecutive surgically treated IST patients were reviewed. In all cases TachoSil® associated with fibrin glue was used as dural sealant. Mean age was 58.14 ± 15.56 years and mean follow-up (FU) was 23.20 ± 9.76 months. The Modified McCormick Scale (MMS) was used to assess the functional status of patients pre-operatively and at latest FU. All article dealing with the use of TachoSil® in spine surgery were included in the literature review. A CSF collection (treated conservatively with needle aspiration and bed rest with no consequence) was observed only in 1 out of 35 cases. No wound infection nor adverse reaction to the TachoSil® occurred during the FU. At latest FU we observed an improvement of MMS grade in 23 patients (65.71%) and a stable functional status in 12 cases (34.28%). According to our experience and the literature review using the TachoSil® after dural closure is safe and effective in IST surgery. Better standardized studies are needed to establish the usefulness of TachoSil® for incidental dural tear in degenerative spine surgery.

Early Repair of Post-hysterectomy Vesicovaginal Fistulae Through a Laparoscopic Transperitoneal Extravesical Approach. Experience of a Single Center

To verify the feasibility and effectiveness of the correction of vesicovaginal fistulae (VVF) through a laparoscopic transperitoneal extravesical approach and TachoSil application as interposition tissue. VVF are the most common fistulae of the urinary tract and even today there is no agreement over the preferred approach to treat this kind of pathologic condition. We retrospectively analyzed the data of women who, from July 2010 to July 2017, underwent early laparoscopic transperitoneal extravesical VVF repair. Patients were placed in the lithotomy position. Five operating ports were placed. After the resection of the VVF, the vesical and vaginal edges were closed in two layers. Finally two layers of TachoSil (4 cm x 4 cm) were placed between the sutures. Several variables were considered in the perioperative period. Patients were re-evaluated at 1 and 3 months after surgery. Sixteen patients underwent VVF repair. Mean duration of the surgery was 106 minutes, mean length of stay was 3.2 days. No high grade complications according to Clavien-Dindo were reported. At 1 month all patients showed complete continence and at 3 months they reported a good quality of life. The laparoscopic approach described enables adequate repair of VVF. The use of Tachosil is straightforward and atraumatic, and may be considered as an alternative to tissue flap interposition. Finally, we confirm that the early approach is not a hazard in such a disabling disease and can be adopted to restore as soon as possible the good quality of life for patients.

Prospective Randomized Controlled Trial Exploring the Effect of TachoSil on Lymphocele Formation After Extended Pelvic Lymph Node Dissection in Prostate Cancer

To explore whether TachoSil, a hemostatic patch, can reduce the incidence of lymphocele formation. Development of a lymphocele is a frequent complication after pelvic lymph node dissection (PLND) for nodal staging in prostate cancer. From 2013 to 2017, 100 patients with prostate cancer who were set to undergo a staging PLND before external beam radiotherapy (n = 50) or PLND concomitant with radical prostatectomy (RP) (n = 50) were prospectively randomized 1:1 between bilateral TachoSil placement or nonplacement. Primary end points were radiographic lymphocele development, lymphocele volume (1 week and 1 month postoperatively), and the duration and volume of postoperative catheter drainage. Patient, tumor, and surgical characteristics of the TachoSil and the control groups did not differ significantly. In total, 65 patients (65%) experienced a radiographic lymphocele up to 3 months after surgery: 29 (58%) in the TachoSil group and 36 (72%) in the control group (P = .34). Significantly less radiographic lymphoceles were observed 1 week postoperatively for patients who underwent sole PLND and 1 month postoperatively for patients who underwent PLND with RP in the TachoSil group compared with the control group (16% vs 48%, P = .024, and 24% vs 52%, P = .047, respectively). The other postoperative characteristics presented no significant differences between the 2 groups, neither for patients undergoing sole PLND nor for patients undergoing PLND with RP. Patients undergoing bilateral TachoSil placement after PLND seem less likely to develop a radiographic lymphocele early postoperatively. Nevertheless, the clinical relevance of the use of TachoSil remains highly debatable.

Editorial Comment on “A Comparative Study Between Two Different Grafts Used as Patches After Plaque Incision and Inflatable Penile Prosthesis Implantation for End-Stage Peyronie’s Disease”

I read with interest the recent article in the Journal of Sexual Medicine comparing the clinical outcomes between fibrin-coated collagen fleece (TachoSil; Baxter Healthcare, Deerfield, IL, USA) and porcine small intestinal submucosa in patients who underwent inflatable penile prosthesis implantation for end-stage Peyronie’s disease (PD).1 In recognition of the oft-repeated phrase in surgery, “there are more ways than one to skin a cat,” numerous substitution graft materials have been used in Peyronie reconstructive surgery.2 TachoSil is a ready-to-use fibrin sealant agent composed of an equine collagen matrix coated with human fibrinogen and thrombin. It has been used in many surgical specialties to improve hemostasis, promote tissue sealing, and support sutures when standard surgical techniques are insufficient.3 A recent systematic review on TachoSil4 showed that it has a role as supportive treatment in surgery to improve and shorten operative time, with potentially lower postoperative complications and hospital costs. However, TachoSil can have problems with intraoperative handling, especially at surgical sites that are difficult to access, and can be associated with higher risks of viral infection or other transferable diseases and stimulate allergic reactions.5 In fact, the Food and Drug Administration has issued warnings that the use of TachoSil can induce thrombosis if applied intravascularly and can potentially transmit infectious agents or cause hypersensitivity or allergic or anaphylactoid reaction.6

Use of TachoSil® to Prevent Symptomatic Lymphocele after an Aggressive Tumor Debulking with Lymphadenectomy for Advanced Stage Ovarian Cancer. A Pilot Study

Objective: To describe the incidence of symptomatic lymphocele (SLC) after an aggressive tumor debulking surgery and lymphadenectomy in patients with ovarian cancer and peritoneal carcinomatosis with or without TachoSil®. Material and Methods: A pilot retrospective comparative observational study was performed between patients with advanced ovarian cancer International Federation of Gynecology and Obstetrics stages III-IV who underwent complete debulking surgery and radical retroperitoneal lymphadenectomy. In 18 patients, 4 TachoSil® patches were placed in the retroperitoneal area, since January 2014-October 2014. This group was compared with other 18 consecutive patients matched by age, International Federation of Gynecology and Obstetrics stage, surgical complexity, American Society of Anesthesiologists score, comorbidity, and BMI without the use of TachoSil®. Results: Baseline characteristics were similar between groups. There were no statistically significant differences in terms of surgical complexity, surgical time, estimated blood loss, node removed, length of hospital stay, and complications between groups. SLC was diagnosed in 7 patients (38.8%) without TachoSil®, and in 2 patients (11.1%) with TachoSil® (p = 0.121). The use of TachoSil® was associated with a statistically significant lower re-admission rate (p = 0.041) and with a significantly shorter time to adjuvant chemotherapy (p = 0.02). Conclusions: Using TachoSil® in women with advanced stage ovarian cancer who underwent radical debulking with retroperitoneal lymph node dissection is associated with a non-statistically significant reduction in the incidence of SLC. A larger-scale randomized controlled study should be conducted to confirm our preliminary results.

Use of absorbable fibrin sealant patch (Tachosil) for hemostasis in split liver transplantation

Introduction: Split liver transplantation (SLT) now reaches similar results as whole liver transplantation (WLT), but is not free of complications, such as hemorrhage and bile leak from cut surface area. An absorbable fibrin sealant patch (TachoSil) may be used by liver surgeons to improve hemostasis control from the cut surface. The objective was to assess the efficacy of TachoSil to improve hemostasis control from cut surface area in patients undergoing to split liver transplantation (SLT). Material and methods: From May 2000 to January 2014, all adult patients undergoing a SLT with right/right extended grafts were retrospectively included and divided into two groups according to the use of TachoSil on the cut surface. Donor and recipient characteristics, blood transfusion rate, aspirin use, postoperative complications and biology were recorded. Results: Among 57 patients who underwent SLT, 23 (40.3%) had TachoSil and 34 (59.6%) didn't. The two groups characteristics were comparable (age, gender, BMI, Child, Meld, indication of liver transplantation). A mean of 2 patch per patient were used in TachoSil group. The blood transfusion rate during SLT was not different between the two groups (11 with TachoSilÒ versus 18 without TachoSil (p = 0.79)), but the mean number of packed red blood cells per patient was significantly lower in the TachoSil group (2.6 versus 8.3 units, p = 0.04). Conclusion: TachoSil use during SLT can be helpful in hemostasis control from cut surface, since when blood transfusion is needed, the number of packed red blood cells used is significantly lower.

A simple and effective method to apply TachoSil® Tissue Sealing sheet using Esmarch's bandage.

We report a novel hemostatic method for using hemostatic patches impregnated with human fibrinogen and thrombin (TachoSil®) together with Esmarch's bandage. The combined use of TachoSil® with Esmarch's bandage is easy and inexpensive. Further, it would ensure sustained and appropriate pressure on the bleeding site, while providing further adhesive strength to TachoSil® at the site.

Use of TachoSil® patches to prevent pancreatic leaks after distal pancreatectomy: a prospective, multicenter, randomized controlled study

We performed a prospective, multicenter, randomized controlled study to investigate the clinical outcomes, including postoperative pancreatic fistulas (POPF), after using the TachoSil® patch in distal pancreatectomy (NCT01550406). Between June 2012 and September 2014, 101 patients at five centers were randomized into Control (n=53) and TachoSil (n=48) groups. In all patients, the pancreas was resected using a stapler with Endo-GIA™ staples. The TachoSil patch was wrapped around the pancreatic stump only in the TachoSil group, not in Control group. The patient characteristics, including age and diagnosis, were comparable in both groups. The mean operation time (159.4 vs. 172.3min, P=0.081) and postoperative hospital stay (10.0 vs. 9.7days, P=0.279) were similar in the Control and TachoSil groups, respectively. The overall incidence of POPF was 62.4% (n=63). The distribution of grades A, B, and C POPF was similar in the Control (n = 14/14/1) and TachoSil (n = 23/11/0) groups, as were the overall incidence (54.7% vs. 70.8%, P=0.095) and the incidence of grade B and C POPF (28.3% vs. 22.9%, P=0.536). This study showed that the TachoSil® patch did not reduce the incidence of POPF after distal pancreatectomy.

Efficacy of TachoSil, a Fibrin-Based Hemostat, for Anterior Lumbar Spine Surgery.

Study DesignRetrospective case series.PurposeTo examine the efficacy of TachoSil for vessel injury in 6 patients who underwent anterior lumbar fusion surgery (ALF).Overview of LiteratureALF for the lumbar spine has a high rate of success, although intraoperative concerns and iatrogenic complications are known, and injury of a major vessel is sometimes a complication. The efficacy of TachoSil, a fibrin-based hemostat, has been reported for several types of surgery; however, use of TachoSil for ALF surgery has not been described. Here, we report on the efficacy of TachoSil in 6 patients, who underwent ALF after vascular surgeons having difficulty in repairing vessels.MethodsTwo man and 4 women with average age of 50.8±10.9 (mean±standard deviation) were diagnosed with a vertebral tumor (2 patients), L4 degenerative spondylolisthesis (2 patients), and L5 spondylolytic spondylolisthesis (2 patients) and underwent ALF. The blood vessels injured included the common iliac vein in 2 patients and a branch of a segmental artery from the aorta in 4 patients. We consulted a vascular surgeon to suture or repair the vessels during surgery, and although the vascular surgeon attempted to address the injuries, suturing or repair was not possible in these cases. For this reason, we used TachoSil to repair the injury in the vessels walls or to stop the bleeding.Results Time to pressure hemostasis using TachoSil was 34±12 minutes, and total blood loss was 1,488±1,711 mL. Nevertheless, all vessel injuries were controlled by the use of TachoSil.ConclusionsWe recommend the use of TachoSil for vessel injuries that vascular surgeons cannot suture or repair during ALF surgery.

Fibrinogen-thrombin collagen patch reinforcement of high-risk colonic anastomoses in rats.

AIMTo evaluate the effectiveness of human fibrinogen-thrombin collagen patch (TachoSil®) in the reinforcement of high-risk colon anastomoses.METHODSA quasi-experimental study was conducted in Wistar rats (n = 56) that all underwent high-risk anastomoses (anastomosis with only two sutures) after colectomies. The rats were divided into two randomized groups: Control group (24 rats) and treatment group (24 rats). In the treatment group, high-risk anastomosis was reinforced with TachoSil® (a piece of TachoSil® was applied over this high-risk anastomosis, covering the gap). Leak incidence, overall survival, intra-abdominal adhesions, and histologic healing of anastomoses were analyzed. Survivors were divided into two subgroups and euthanized at 15 and 30 d after intervention in order to analyze the adhesions and histologic changes.RESULTSOverall survival was 71.4% and 57.14% in the TachoSil® group and control group, respectively (P = 0.29); four rats died from other causes and six rats in the treatment group and 10 in the control group experienced colonic leakage (P > 0.05). The intra-abdominal adhesion score was similar in both groups, with no differences between subgroups. We found non-significant differences in the healing process according to the histologic score used in both groups (P = 0.066).CONCLUSIONIn our study, the use of TachoSil® was associated with a non-statistically significant reduction in the rate of leakage in high-risk anastomoses. TachoSil® has been shown to be a safe product because it does not affect the histologic healing process or increase intra-abdominal adhesions.

The contribution of a collagen–fibrin patch (Tachosil) to prevent the postoperative lymphatic complications after groin lymphadenectomy: a double institution observational study

ObjectivePostoperative morbidity associated with groin lymphadenectomy remain high and still represents a major concern for this patients. The aim of this study was to confirm the efficacy of TachoSil® in preventing postoperative complications after inguinofemoral lymphadenectomy for gynecological malignancy. Study designAn observational study was conducted to evaluate the incidence of postoperative complications among 49 patients (TachoSil® group=24; control group=25) underwent groin dissection enrolled in two Italian Department of Gynecology Oncology from 2011 to 2014. ResultsA total of 74 inguinal dissections were performed. Bilateral groin dissection was performed in 25 patients (Tachosil group=10; group 2=15). Patients in TachoSil® group showed a lower daily drainage volume with a mean volume of 84ml (range 30–465) vs. 143ml (range −72 to 413) in the control group (p=.004), and a lower total drainage volume with a mean of 540ml (range 90–930) vs. 900ml (range 200–3270) for Tachosil and control group, respectively. A lower incidence of lymphocyst required drainage, cellulitis, wound infection and late lymphedema was observed in TachoSil group even without reaching statistical significance. ConclusionsThis observational study confirmed that the use of TachoSil® seems to be highly effective in reducing the rate of postoperative lymphorrea and postoperative complications after groin dissection in case of gynecological malignancies. Larger multicenter prospective study is advisable to validate our preliminary results.