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A Flexible Hemostasis & Sealing Solution

In pediatric surgery, the broad spectrum of indications from multiple specialties presents a challenge to all pediatricians seeking for aids to achieve safe hemostasis and sealing.

As your pediatric patients are not small adults, their metabolism, growth, physical and mental development are special and so need special treatment. A customized care makes a very big difference and initiated Corza Medical to evaluate the registration of our hemostasis and sealing solution to very defined indications for this group of patients.

As the majority of surgical solutions are dedicated to adult patients, the most recent 2023 EMA approval of our hemostasis and sealing solution for pediatric patients greater than 1 month of age* has the potential to augment your portfolio of solutions to fight hemorrhage and leakages.

TachoSil® is a ready-to-use fixed combination of collagen patch and active coagulation factors to improve hemostasis.

Moreover, sealing capabilities to provide suture support in vascular surgery and prevention of body liquid as well as air leakages are highly demanded. Liquid tight suture hole sealing on top of accelerating the hemostatic cascade are values of TachoSil® as a dual-action-patch in a range of pediatric indications demonstrated by evidence based medicine.

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The Benefits of Corza Medical’s Hemostasis & Sealing Solution in Pediatric Surgery

  • Very good tolerance
  • Extremely high operational safety and reliability
  • Very quick to use
  • Immediate success of the application recognizable
  • Avoidance/reduction of operational risks
  • Reduction of operating times
  • Reduction of transfusion risk
  • Increased safety for patients

Most important surgical procedures and areas of application in pediatric surgery

Applications in Pediatric Cardiovascular Surgery:

  • Botall’s artery ductus patent – PDA
  • Aortic coarctation
  • septal defect – ASD
  • Transposition of great arterial trunks – TGA
  • Left heart hypoplasia syndrome – HLHS
  • Tetralogy of Fallot – TOF
  • Common atrioventricular canal – CAVC
  • Common artery trunk – TAC
  • Congenital obstruction of the gastrointestinal tract (i.e. congenital obstruction of the esophagus, of the small and large intestine)
  • Appendicitis
  • Hernia
  • Meckel diverticle
  • Esophagus: atresia with/without fistula
  • Intestinal atresia
  • Pancreatic tail resections
  • Lung malformations (congenital)
  • Distance sequester
  • Partial removal of lung tissue
  • Diaphragmatic defects
  • Chest malformations (funnel chest)
  • Nuss-procedure
  • Pectus excavatus
  • Inflammation (lung abscesses, pleural rind)
  • Endoscopic and open thoracotomy procedures (VATS)
  • Thoracic injuries
  • Sealing pulmonary leakages
  • Bladder extrophy
  • Testicular torsion
  • Ovarian torsion
  • Cervical fistula
  • Phimosis
  • Operation of urethral valves
  • Correction of penile malformations
  • Bony fractures of extremities, rib cage, pelvis, spine, skull, etc.
  • Special spina bifida and hydrocephalus surgery
  • Pediatric plastic surgery with burn medicine
  • Cuts, lacerations, traffic accidents
  • Esophagus: atresia with/without fistula
  • Intestinal atresia
  • Idiopathic scoliosis
  • Gut – duplicate
  • Diaphragmatic atresia
  • Biliary atresia
  • Bladder extrophy
  • Anal atresia
  • Hirschsprung disease
  • Neuroblastoma
  • Hepatoblastoma
  • Nephroblastoma (Wilms’ tumors)
  • Soft tissue sarcomas
  • Ovarian tumors
  • Tumors pancreas
  • Thyroid cancer
  • Liver transplantation
  • Kidney transplantation
  • Multiorgan transplantation (kidney, liver, intestine)

Examples of performance in selected pediatric procedures

Use of in Liver Transplantation

Prospective, single centre clinical trial in comparison to a historical cohort, with prospective data collection.

Pediatric patients with the need of liver transplantation with the ex-situ liver transection technique and with the use of Corza Medical’s hemostasis and sealing solution®.

Efficacy and safety of TachoSil® after liver transplantation.

  • TachoSil® group (n = 21)
  • Control group (n = 59).

This study showed that an aortic dissection can be supported by a TachoSil® sandwich. This is feasible, safe and effective with respect to the repair of torn aortic tissue.

Endpoints

  • Bleeding of the wound area, biliary leak.

Results

  • The characteristics of recipients and donors were similar.
  • There were fewer reoperations due to bleeding in the wound area in the TachoSil® group (14.2%) compared to the control group (41.7%, p=0.029).
  • There was no difference in relation to the biliary leak (TachoSil® group: 17.6%, control group: 5.1%, p=0.14).

Conclusion

There was a lower number of reoperations due to bleeding of the wound area of the hepatic graft when TachoSil® was used.

References

Vicentine FP et al. Pediatric Liver Transplantation with ex-situ Liver Transection and the Application of the Human Fibrinogen and Thrombin Sponge in the Wound Area. Arq Bras Cir Dig. 2016 Nov-Dec;29(4):236-239.

 


Fig. 1. Hepatic graft submitted to split with formation of two functional liver grafts: A) graft for the adult; B) graft for the child

Figure 1. A–E: Human dissected aorta is shown (A). The collagen matrix is either folded or two separate pieces are brought together on the non-coated sides (B, C). The double layer construct is cut as desired, rinsed with cold saline, and placed between tissues to cover as much as possible of the depth of the dissection (D). The repaired aorta is shown. The matrix double layer reconnects and reinforces the dissected aortic tissue (E).

Use of in Liver Resection

Prospective, open-label, single arm, multicentric trial in children (aged 4 weeks to 6 years).

Children with liver resection with or without segmental liver transplantation were treated with TachoSil®, if minor (i. e., oozing) or moderate bleeding was present after primary hemostatic treatment.

16 children were enrolled, 13 children with whole liver resection, 3 with segmental resection.

Primary and Secondary Endpoints

  • Time to hemostasis after TachoSil® application
  • Safety – number of adverse events and related to the use of TachoSil®

Results

  • Satisfactory haemostasis was achieved in 13 children (81.3 % ; 95 % CI: 61.8 – 100 %) at 3 min and in 1 child at 8 min.
  • A total of 108 adverse events (AE) were reported. No AEs were considered to be related to the use of TachoSil®.

Conclusion
The use of TachoSil® for haemostasis after primary haemostatic treatment appears to be safe and effective in children undergoing liver resection.

References
Mirza D et al. The use of TachoSil® in children undergoing liver resection with or without segmental liver transplantation. Eur J Pediatr Surg. 2011 Mar;21(2):111-5.

Use in Children with Congenital Heart Disease

Retrospective, single arm, single centre trial in children (≤ 16 years) who underwent a reoperation for treating their congenital heart disease between 01/2009 and 12/2011.

Objective

efficacy and cost-effectiveness of TachoSil® during intraoperative hemostasis.

117 patients were included. Median age at was 2.1 years (range 3 days-14.1 years).Main causes of intraoperative bleeding were:

  1. reinforcement of suture lines (106 patients, 90.6%);
  2. lung lesions (5 patients, 4.2%);
  3. epicardial lesions (3 patients, 2.6%); and
  4. chest wall lesions (3 patients, 2.6%).

Endpoints

Efficacy and cost-effectiveness of TachoSil® during intraoperative hemostasis

Results

The use of TachoSil® (n=90 patients) was significantly associated with a lower packed red blood cells requirement (P=0.0003, OR=0.1) which in addition to the avoidance of other hemostatic/sealant agents, leads to lower hospital cost.

Conclusion

TachoSil® is an effective hemostatic agent which can be safely used during the hemostasis of children requiring reoperations for their congenital heart malformations. The use of TachoSil reduces hospital costs by limiting the need for intraoperative blood transfusion and the use of other hemostatic/sealing agents.

References

Vida VL The use fibrinogen/thrombin-coated equine collagen patch in children requiring reoperations for congenital heart disease. A single center clinical experience. J Cardiovasc Surg (Torino). 2014 Jun;55(3):401-6. PMID: 24755705.

Efficacy in controlling lymphatic leaks

Single arm, single centre, case report series in children (≤ 4 years) who underwent heart surgery for congenital heart disease and developed an intraoperative lymphatic leakage.

Endpoints

Use of TachoSil®  for efficacy and safety in preventing intra-operative lymphatic leaks and the development of postoperative chylothorax.

Results

6 patients were included. Median age was 8.8 months (range 5 to 38 months). In all children TachoSil® stopped the lymphatic leak.

Conclusion

The use of TachoSil® proved to be safe and effective in preventing the development of postoperative chylothorax.

References

Vida VL Efficacy of TachoSil® in controlling lymphatic leaks. J Card Surg. 2012 Jul;27(4):441-2.

Use for reoperation in pediatric cardiac surgery

Single-arm case report series from a single center for 25 cardiac reoperations for correction of congenital heart defects. The mean age of the patients was 8 years.

Approach and objectives

TachoSil® was applied to the extracardiac sutures and to cover the anastomosis for hemostasis.

Results

The bleeding was stopped and the surgical procedures were successfully completed.

Conclusion

The postoperative course was uneventful/regular in all patients. No patient required reoperation due to bleeding.

References

Giordano R Use of biological hemostatic support TachoSil® for reoperation in pediatric cardiac surgery.

Minerva Pediatr. 2016 Jun;68(3):240-1. PMID: 27125443.

Use in Nephron Sparing Surgery (NSS)

3 Case reports, prospective, open-label, single centre trial (06/2010 to 01/2011).

Primary outcome measures were intraoperative bleeding control and surgery-related postoperative sequelae.

3 children (6 to 45 months) with Wilms tumor (synchronous bilateral in one) undergoing nephron sparing surgery (NSS).
Overall, 4 kidneys underwent 5 NSS procedures.

After control of major bleeding and suturing of the collecting system (in 2 of the 5 NSS procedures) TachoSil® was applied to the parenchymal surface of the kidney.

Results

Hemostasis in all NSS procedures with TachoSil®.

All NSS procedures were performed without hilar clamping, drainage or stent placement and none of the patients required blood transfusion.

Small perirenal fluid collections were documented postoperatively, and all spontaneously resolved within 4 weeks of surgery.

Conclusion

In children undergoing NSS, TachoSil® represents an effective and safe tool for control of mild to moderate bleeding, and also facilitates sealing and wound dressing.

References

Mele E. The use of Tachosil as hemostatic sealant in nephron sparing surgery for Wilms tumor: preliminary observations. J Pediatr Surg. 2013 Mar;48(3):689-94.

Use in Lung Surgery

Two case reports, open label, single centre trial.

Lung resection for benign diseases in children with secondary pneumothorax.
One 9-months-old boy and one 13-month-old girl were treated with TachoSil® after lung surgery to stop air leakage.

The air leaks in both cases could be sealed with TachoSil®.

References

Molnar TF. A new method for coping with lung parenchyma destruction in paediatric thoracic surgery. Eur J Cardiothorac Surg. 2008 Sep;34(3):675-6


TachoSil® covers the underlying atypically resected surface of the lung under full inflation. The coverage is completely airtight after 10 min tested by water-filling.

Use in Lung Surgery

Case report from a 12-year-old girl with a previous diagnosis of Marfan syndrome (MFS) and recurrent history of left spontaneous pneumothorax.

A thoracoscopic atypical lung resection was performed and two patches (9.5 × 4.8 cm) of TachoSil® were applied and were pressed against the sutured area as supportive treatment.

The patient recovered with no further spontaneous pneumothorax recurrences.

Conclusions

The use of TachoSil® may be useful in pneumothorax supportive treatment, particularly in pediatric MFS by ameliorating the mechanical strength of the lung.

References

Pelizzo G et al. Thoracoscopic Treatment of Pneumothorax in Marfan Syndrome: Hemostatic Patch to Support Lung Resection Recovery. Case Rep Surg. 2018 Sep 4;2018:7597215.

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Pediatric Case Reports & Resources

Interesting facts about Pediatric Surgery
TachoSil® Pediatric Brochure
Use of TachoSil® for efficient hemostasis during emergency exploratory thoracotomy in a 13-year-old boy
Use of TachoSil® for efficient hemostasis and sealing after tumor resection in an 11-month-old child
Use of TachoSil® after laparoscopic excision of an enormous hepatic cyst in an 18-month-old child
Use of TachoSil® for sufficient sealing of a vein interposition for acute occlusion of the brachial artery in a 5-year-old child

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Corza hemostasis and sealing solution in pediatric surgery

Clinical publications and further literature

  1. Corrective surgery using a gridiron incision for abdominal pain caused by a folded ovary in the third trimester of pregnancy. Kim AM, Kim JW, Kim YH, Kim TY, Ryu HK, Choi MG. J Int Med Res. 2021 Mar;49(3):300060521997743. doi: 10.1177/0300060521997743. PMID: 33729868
  2. Plaque incision and Tachosil graft in Peyronie’s Disease. de Sallmard G, Morel-Journel N, Sbizzera M, Hanquiez P, Ruffion A, Terrier JE. Prog Urol. 2020 Feb;30(2):119-125. doi: 10.1016/j.purol.2019.11.011. Epub 2020 Feb 14. PMID: 32067908
  3. Liquorrhea after removal of fourth ventricle tumors in children. Retrospective analysis of a series of 211 primary surgeries. Kushel’ YV, Danilov GV, Tekoev AR, Chel’diev BZ, Strunina YV. Zh Vopr Neirokhir Im N N Burdenko. 2018;82(5):39-47. doi: 10.17116/neiro20188205139. PMID: 30412155
  4. Cisterna magna arachnoid membrane suturing decreases incidence of pseudomeningocele formation and incisional CSF leakage. Pitskhelauri D, Kudieva E, Moshchev D, Ananev E, Shifrin M, Danilov G, Melnikova-Pitskhelauri T, Kachkov I, Bykanov A, Sanikidze A. Acta Neurochir (Wien). 2018 May;160(5):1079-1087. doi: 10.1007/s00701-018-3507-y. Epub 2018 Mar 20. PMID: 29557532
  5. Sealing of the hepatic resection area using hemostat devices does not improve results of adequate surgery. Petersen M, Steinert R, Jannasch O, Venerito M, Meissner C, Kropf S, Albrecht R, Lippert H, Meyer F. Z Gastroenterol. 2016 Jul;54(7):634-41. doi: 10.1055/s-0042-100284. Epub 2016 Jul 18. PMID: 27429100.
  6. Efficacy of Human Fibrinogen-Thrombin Patch (TachoSil) Clinical Application in Upper Gastrointestinal Cancer Surgery. Marano L, Di Martino N. J Invest Surg. 2016 Dec;29(6):352-358. doi: 10.1080/08941939.2016.1181229. Epub 2016 May 18. PMID: 27191688
  7. Use of biological hemostatic support TachoSil® for reoperation in pediatric cardiac surgery. Giordano R, Palma G, Palumbo S, Cioffi S, Russolillo V, Vosa C. Minerva Pediatr. 2016 Jun;68(3):240-1. PMID: 27125443
  8. Comparative study of long term result of auto- and allografts for keratinized gingiva restoration in vestibuloplasty area on the lower jaw. Grudianov AI, Nikolaev AV. Stomatologiia (Mosk). 2016;95(1):40-43. doi: 10.17116/stomat201695140-43. PMID: 26925565 Russian.
  9. Experiences with TachoSil® in microneurosurgery. Kivelev J, Göhre F, Niemelä M, Hernesniemi J. Acta Neurochir (Wien). 2015 Sep;157(8):1353-7; discussion 1357. doi: 10.1007/s00701-015-2473-x. Epub 2015 Jul 3. PMID: 26136196
  10. The efficacy of TachoComb on reducing postoperative complications after tonsillectomy in children. Kim YW, Kang MJ, Lee HJ, Woo CK, Mun MJ, Cho KS. Int J Pediatr Otorhinolaryngol. 2015 Aug;79(8):1337-40. doi: 10.1016/j.ijporl.2015.06.006. Epub 2015 Jun 12. PMID: 26100056
  11. A collagen-fibrin patch (Tachosil®) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial. Grimm C, Polterauer S, Helmy S, Cibula D, Zikan M, Reinthaller A, Tempfer C. BMC Cancer. 2014 Aug 30;14:635. doi: 10.1186/1471-2407-14-635. PMID: 25175029
  12. The use fibrinogen/thrombin-coated equine collagen patch in children requiring reoperations for congenital heart disease. A single center clinical experience. Vida VL, De Franceschi M, Barzon E, Padalino MA, Scattolin F, Stellin G. J Cardiovasc Surg (Torino). 2014 Jun;55(3):401-6. PMID: 24755705
  13. The use of Tachosil as hemostatic sealant in nephron sparing surgery for Wilms tumor: preliminary observations. Mele E, Ceccanti S, Schiavetti A, Bosco S, Masselli G, Cozzi DA. J Pediatr Surg. 2013 Mar;48(3):689-94. doi: 10.1016/j.jpedsurg.2013.01.019. PMID: 23480936
  14. Capillary ENT hemangioma. Antoniv TV. Vestn Otorinolaringol. 2012;(1):11-3. PMID: 22678630
  15. Efficacy of fibrinogen/thrombin-coated equine collagen patch in controlling lymphatic leaks. Vida VL, Padalino MA, Barzon E, Stellin G. J Card Surg. 2012 Jul;27(4):441-2. doi: 10.1111/j.1540-8191.2012.01461.x. Epub 2012 May 14. PMID: 22583120
  16. Effect of fibrin-coated collagen fleece (TachoComb) on pain and bleeding after adenotonsillectomy in children. Nam JG, Lee TH, Kwon JK, Lee JC, Lee SR, Lee SM, Lee HM. Acta Otolaryngol. 2011 Dec;131(12):1293-8. doi: 10.3109/00016489.2011.611533. Epub 2011 Sep 9. PMID: 21905793
  17. Effect of TachoSil patch in prevention of postoperative pancreatic fistula. Pavlik Marangos I, Røsok BI, Kazaryan AM, Rosseland AR, Edwin B. J Gastrointest Surg. 2011 Sep;15(9):1625-9. doi: 10.1007/s11605-011-1584-9. Epub 2011 Jun 14. PMID: 21671113
  18. The use of TachoSil in children undergoing liver resection with or without segmental liver transplantation. Mirza D, Millar AJ, Sharif K, Vilca-Melendez H, Rela M, Heaton N. Eur J Pediatr Surg. 2011 Mar;21(2):111-5. doi: 10.1055/s-0030-1267221. Epub 2011 Apr 14. PMID: 21494994
  19. Prevention of cerebrospinal fluid rhinorrhea after transsphenoidal surgery by collagen fleece coated with fibrin sealant without autologous tissue graft or postoperative lumbar drainage. Cho JM, Ahn JY, Chang JH, Kim SH. Neurosurgery. 2011 Mar;68(1 Suppl Operative):130-6; discussion 136-7. doi: 10.1227/NEU.0b013e318207b4ea. PMID: 21206312
  20. Foreign body granuloma mimicking upper cervical spinal mass after dural repair with Tachocomb [correction of Tachocomp]: a case report. Ekici MA, Ekici A, Per H, Tucer B, Kurtsoy A. Pediatr Neurosurg. 2010 Aug;46(2):133-7. doi: 10.1159/000319397. Epub 2010 Jul 28. PMID: 20664302
  21. Application of “Tachocomb” preparation in pediatric surgery. Krivchenia DIu, Dubrovin AG, Dan’shin TI, Pritula VP, Povorozniuk VS, Sil’chenko MI, Grishin AA, Maksakova IS, Parkhomenko VV. Klin Khir. 2010 Mar;(3):52-5. PMID: 20491260
  22. Reduction in bile leaks following adult split liver transplant using a fibrin-collagen sponge: A pilot study. Toti L, Attia M, Manzia TM, Lenci I, Gunson B, Buckels JA, Mirza DF, Mayer AD, Bramhall SR, Wigmore SJ. Dig Liver Dis. 2010 Mar;42(3):205-9. doi: 10.1016/j.dld.2009.06.010. Epub 2009 Nov 12. PMID: 19913466
  23. A new method for coping with lung parenchyma destruction in paediatric thoracic surgery. Molnar TF, Farkas A, Stankovics J, Horvath OP. Eur J Cardiothorac Surg. 2008 Sep;34(3):675-6. doi: 10.1016/j.ejcts.2008.06.032. Epub 2008 Jul 25. PMID: 18656376
  24. Results of Destandau microendoscopic lumbar discectomy. Lysoń T, Mariak Z, Jadeszko M, Kochanowicz J, Lewko J. Neurol Neurochir Pol. 2008 Mar-Apr;42(2):105-11. PMID: 18512166
  25. Non-surgical management of patients with blunt abdominal injury: the role of angiography. Turculeţ C, Popa B, Palea M, Venter D, Feodor T, Dinescu G. Chirurgia (Bucur). 2008 Jan-Feb;103(1):79-85. PMID: 18459502
  26. Fibrin-collagen patch (TachoComb) in general surgery. Indications and results. Târcoveanu E, Lupaşcu C, Moldovanu R, Vlad N, Bradea C, Vasilescu A. Rev Med Chir Soc Med Nat Iasi. 2007 Apr-Jun;111(2):396-401. PMID: 17983175
  27. Successful continuation of pregnancy after repair of a midgestational uterine rupture with the use of a fibrin-coated collagen fleece (TachoComb) in a primigravid woman with no known risk factors. Shirata I, Fujiwaki R, Takubo K, Shibukawa T, Sawada K. Am J Obstet Gynecol. 2007 Oct;197(4):e7-9. doi: 10.1016/j.ajog.2007.07.039. PMID: 17904953
  28. Use of fibrinocollagen complex in surgical treatment of patients with vascular tumors of the ear and external nose (a pilot report). Antonov VF, Efimochkina KV. Vestn Otorinolaringol. 2007;(3):30-2. PMID: 17690654
  29. The use of a surgical patch coated with human coagulation factors in surgical routine: a multicenter postauthorization surveillance. Haas S. Clin Appl Thromb Hemost. 2006 Oct;12(4):445-50. doi: 10.1177/1076029606293420. PMID: 17000889
  30. Current ways of preventing postresectional bronchial fistulas in pulmonary tuberculosis]. Rakishev GB, Chaĭmerdenov SCh, Klenin VV, Egemberdiev ZhT, Erimbetov KD, Firsov VI, Sundetov MM. Probl Tuberk Bolezn Legk. 2005;(2):22-4. PMID: 15881963
  31. Problems of hemostasis and hermetic properties in liver resections with application of fibrin-collagen substance]. Bunatian AG, Zavenian ZS, Bagmet NN, Shatverian GA, Skipenko OG. Khirurgiia (Mosk). 2003;(9):18-23. PMID: 14533376
  32. Surgery of anterior skull base fractures. Aletsee C, Konopik V, Dazert S, Dieler R. Laryngorhinootologie. 2003 Sep;82(9):626-31. doi: 10.1055/s-2003-42688. PMID: 14517758
  33. Innovative minimally invasive pediatric surgery is of therapeutic value for splenic injury. Carbon RT, Baar S, Waldschmidt J, Huemmer HP, Simon SI. J Pediatr Surg. 2002 Aug;37(8):1146-50. doi: 10.1053/jpsu.2002.34460. PMID: 12149690
  34. The application and evaluation of TachoComb in repair of lacerations of dural sac. Kaczmarczyk R, Markiewicz P, Trojanowski T. Neurol Neurochir Pol. 2001;35 Suppl 5:64-9. PMID: 11935684
  35. Minimal invasive pediatric surgery: development and progress by innovative technology. Carbon RT, Baar S, Waldschmidt J, Hümmer HP, Simon S. Klin Padiatr. 2001 May-Jun;213(3):99-103. doi: 10.1055/s-2001-15858. PMID: 11417369
  36. New approaches to tissue management in minimal invasive pediatric surgery]. Carbon RT, Thias M, Schreiber M, Simon SI, Mughrabi H, Hümmer HP. Langenbecks Arch Chir Suppl Kongressbd. 1998;115:1175-8. PMID: 9931827
  37. Application of wound coat “Tachocomb” in surgical interventions on liver and pancreas]. Skipenko OG, Shatverian GA, Movchun AA, Eramishantsev AK. Khirurgiia (Mosk). 1998;(1):11-4. PMID: 9511288
  38. Hemostatic efficacy and safety of TachoComb in surgery. Ready to use and rapid hemostatic agent. Agus GB, Bono AV, Mira E, Olivero S, Peilowich A, Homdrum E, Benelli C. Int Surg. 1996 Jul-Sep;81(3):316-9. PMID: 9028999

Prescribing Information

Refer to Summary of Product Characteristics (SmPC) before prescribing.

Presentation: An off-white sponge coated with human fibrinogen 5.5 mg and human thrombin 2.0 IU per cm2. The active side of the sponge is marked by a yellow colour. Supplied, ready to use, in sterile packaging. Indications: In adults and children from 1 month old, for supportive treatment in surgery for improvement of hemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient; also in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurosurgical procedures. Dosage & Administration: For epilesional use only. Use is restricted to experienced surgeons. The number of sponges to be used is governed by the size of wound area, and the underlying clinical need for the patient. In clinical trials the individual dosages have typically ranged from 1–3 sponges. Sponges should be used under sterile conditions and immediately after opening the inner sterile cover. Prior to application, the wound area should be cleansed, e.g. from blood, disinfectants and other fluids. The sponge should be pre-moistened in saline solution and applied immediately. The yellow, active side of the sponge is applied to the bleeding/leaking surface and held against it with a gentle pressure for 3–5 minutes. Pressure is applied with moistened gloves or a moist pad. If covered with blood, surgical instruments and gloves may be pre-moistened with physiological saline solution to avoid the sponge sticking to them. After pressing the sponge to the wound, the glove or the pad must be removed carefully. To avoid the sponge from being pulled loose it may be held in place at one end, e.g. with a pair of forceps. In the case of stronger bleeding, it may be applied without pre-moistening, while also pressing gently to the wound for 3–5 minutes. The sponge should be applied so that it extends 1–2 cm beyond the margins of the wound. Sponges should be overlapped if more than one is used and can be cut to the correct size and shaped if too large. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Contraindications: Intravascular use; hypersensitivity to the active substances or to any of the excipients. Warnings & Precautions: No specific data available on the use of this product in gastrointestinal anastomosis surgery. Allergic type hypersensitivity reactions are possible, as with any protein product. If hypersensitivity reactions occur, the administration must be discontinued immediately. In the case of shock, the current medical standards should be followed. Standard measures to prevent infections from products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV. Measures may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for immunodeficient patients or those who have increased erythropoiesis e.g. hemolytic anaemia. Risk of transmission of infective agents cannot be totally excluded, including pathogens of hitherto unknown nature. It is recommended to record the name and the batch number of the product administered to the patient. Interactions: No formal interaction studies have been performed. In comparable products or thrombin solutions, the sealant may be denatured after exposure to solutions containing alcohol, iodine, or heavy metals. Fertility, pregnancy & lactation: Safety use in human pregnancy or breastfeeding has not been established. Only administer to pregnant and breastfeeding women if clearly needed. Undesirable Effects: Hypersensitivity or allergic reactions (in rare cases these reactions may progress to severe anaphylaxis; some cases of product residue causing granuloma); thromboembolism may occur if unintentionally used intravascularly, and adhesions and intestinal obstruction when used in abdominal surgery. Refer to the SmPC for details on full side effect profile and interactions. Marketing Authorisation Holder: Corza Medical GmbH, Speditionstrasse 21, 40221 Düsseldorf, Germany. Marketing Authorisation Numbers: EU/1/04/277/001-005.

Date of revision of the text: March 2023

Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA)

http://www.ema.europa.eu/

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