Клинические исследования
Применение имплантируемых сеток Б. Браун для пластики грыж, реконструкции грудной клетки и других задач широко освещено в научной литературе. Для фиксации сетчатых имплантатов при герниопластике доступен также хирургический клей Histoacryl®, чей клинический успех подтвержден более чем в 1200 публикациях.
| Операции на брюшной стенке | Показания | Продукция | Научные работы |
|---|---|---|---|
| Закрытие брюшной стенки | Закрытие брюшной стенки после лапаротомии | Monomax® MonoPlus® | INSECT [01], [02], [03], [04], [05] and ISSAAC [06] |
| Герниопластика брюшной стенки | Открытая операция паховой грыжи по технике Lichtenstein Операция по Rutkow-Robbins Лапароскопическая операция паховой грыжи техниками TAPP/TEP Открытая операция вентральных грыж техниками Onlay/Sublay Открытая или лапароскопическая операция вентральных грыж техникой IPOM | Optilene® Mesh Premilene® Mesh Plug Optilene® Mesh Optilene® Mesh Omyra® Mesh | Prevention of Chronic Pain [10] and Best Mesh-Glue combination for Fixation [07] and Biocompatibility Tissue Integration |
| Фиксация сетчатых имплантатов | Фиксация сетчатых имплантатов в открытой операции паховой грыжи по технике Lichtenstein
Фиксация сетчатых имплантатов в лапароскопической операции паховой грыжи техниками TAPP и TEP | Histoacryl® вместе с Vipro II
Histoacryl® | Sutureless Lichtenstein: Prospective randomized trial comparing sutured with sutureless mesh fixation for Lichtenstein hernia repair: long-term results. |
| Профилактика разрывов абдоминальной стенки после лапаротомии | Лапаротомия при общих состояниях пациента (ожирение, диабет, аневризма брюшной аорты, инфицирование, рак) | Monomax® в сочетании с Optilene® Mesh Elastic или Optilene® Mesh LP или Safil® Mesh | Prophylactic Mesh in Cancer Patients [18], [19] |
Закрытие брюшной стенки — Monomax®
[01] Interrupted or continuous slowly absorbable sutures – design of a multi-centre randomised trial to evaluate abdominal closure techniques INSECT-trial [ISRCTN24023541]. HP. Knaebel, M. Koch, S. Sauerland, MK. Diener, MW. Büchler, CM. Seiler; INSECT Study Group of the Study Centre of the German Surgical Society. BMC Surg, 2005; Mar 8;5:3. Pubmed >>
[02] Operative standardization in randomized controlled surgical trials. Meeting of the INSECT trial. HP. Knaebel, M. Kirschner, M. Reidel, M. Büchler, C. Seiler. MW, Seiler CM. Chirurg, 2006; 77:267-272. (Article in German). Pubmed >>
[03] Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomized surgical trial. CM. Seiler, P. Kellmeyer, P. Kienle, MW. Büchler, HP. Knaebel, the INSECT Study Group. J Med Ethics, 2007; 33:113-118. Pubmed >>
[04] Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541). CM. Seiler, T. Bruckner, MK. Diener, A. Papyan, H. Golcher, C. Seidlmayer, A. Franck, M. Kieser, MW. Büchler, HP. Knaebel. Ann Surg, 2009; 249(4):576-82. Pubmed >>
[05) Current practice of abdominal wall closure in elective surgery – Is there any consensus? NN. Rahbari, P. Knebel, MK. Diener, C. Seidlmayer, K. Ridwelski, H. Stöltzing, CM. Seiler. BMC Surgery, 2009; 9:8. Pubmed >>
[06] A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of Monomax® suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]. L. Fischer, P. Baumann, J. Hüsing, C. Seidlmayer, M. Albertsmeier, A. Franck, S. Luntz, CM. Seiler, HP. Knaebel. BMC Surg, 2008; 8: 12. Pubmed >>
Evaluation of the safety and efficacy of Monomax® suture material for abdominal wall closure after primary midline laparotomy-a controlled prospective multicentre trial: ISSAAC [NCT005725079]. Albertsmeier M, Seiler CM, Fischer L, Baumann P, Hüsing J, Seidlmayer C, Franck A, Jauch KW, Knaebel HP, Büchler MW. Department of Surgery, University of Munich, Grosshadern Campus, Marchioninistr. 15, 81377, München, Germany. Pubmed >>
Герниопластика — Optilene® Mesh LP
[07] Randomized clinical trial of tissue glue versus absorbable sutures for mesh fixation in local anaesthetic Lichtenstein hernia repair. Paajanen H, Kössi J, Silvasti S, Hulmi T, Hakala T. Br J Surg. 2011 Sep;98(9):1245-51. doi: 10.1002/bjs.7598. Epub 2011 Jun 28. Pubmed >>
Clinical Evidence for Optilene® Mesh LP a mesh for inguinal hernia repair.
B. Braun Extranet >>
Герниопластика — Optilene® Mesh Elastic
[08] Early tissue incorporation and collagen deposition in lightweight polypropylene meshes: bioassay in an experimental model of ventral hernia. G. Pascual, M. Rodríguez, V. Gómez-Gil, N. García-Honduvilla, J. Buján, J. M. Bellón. Surgery 2008;144:427-35. Pubmed >>
[09] Comparing the behavior of different polypropylene meshes (heavy and lightweight) in an experimental model of ventral hernia repair. J. M. Bellón, M. Rodríguez, N. García-Honduvilla, V. Gómez-Gil, G. Pascual, J. Buján. Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2008. Pubmed >>
[10] Prevention of Chronic Pain. Optilene® Mesh Elastic vs. Ultrapro® – End 2010. ClinicalTrials >>
[17] Intraperitoneal meshes in the repair of abdominal wall defects: comparison of polyester with collagen versus polypropylene with polyglycolic acid. R. Mendes NG. Czeczko, JM. Ribas-filho, O. Malafaia, VM. Budel, CM. S. Rojas, E. Zimmermann, UA. Dietz. Rev. Col. Bras. Cir., 2009; 36(3): 241-249. SciELO >>
Clinical Evidence for Optilene® Mesh Elastic a mesh for incisional hernia repair.
B. Braun Extranet >>
Герниопластика – Omyra® Mesh
[11] Macroporous condensed poly(tetrafluoroethylene). I. In vivo inflammatory response and healing characteristics. G. Voskerician, PH. Gingras, JM. Anderson. J Biomed Mat Res 2006; 76A: 232-242. Pubmed >>
[12] Macroporous condensed poly(tetrafluoroethylene). II. In vivo effect on adhesion formation and tissue integration. G. Voskerician, A. Rodríguez, PH. Gingras. J Biomed Mat Res 2007; 82: 426-435. Pubmed >>
[13] Laparoscopic intraperitoneal mesh fixation with fibirn sealant (Tisseel®) vs. titanium tacks: a randomised controlled experimental study in pigs. JR. Eriksen, JI. Bech, D. Linnemann, J. Rosenberg. Hernia 2008; 12: 483-491. Pubmed >>
[14] Macroporosity and hydrophobicity of surgical meshes reduce in vivo Staphylococcus aureus infection and anchorage. G. Voskerician, AM. Broome, K. Harth, M. Jacobs, I. Halaweshi, M. Rosen. Hernia 2009; 13 (Suppl 1): S3-S4.
Фиксация сетчатых имплантов — Histoacryl®
[15] Efficiency and safety of mesh fixation in laparoscopic inguinal hernia repair using n-butyl cyanoacrylate: long-term biocompatibility in over 1,300 mesh fixations. Kukleta JF, Freytag C, Weber M. Hernia. 2012 Apr;16(2):153-62. Epub 2011 Oct 21. Pubmed >>
[16] Sutureless Lichtenstein: first results of a prospective randomised clinical trial. Helbling C, Schlumpf R. Hernia. 2003 Jun;7(2):80-4. Epub 2003 Jan 30. Pubmed >>
[17] Prospective randomized trial comparing sutured with sutureless mesh fixation for Lichtenstein hernia repair: long-term results. Kim-Fuchs C, Angst E, Vorburger S, Helbling C, Candinas D, Schlumpf R. Hernia. 2012 Feb;16(1):21-7. Epub 2011 Jul 26. Pubmed >>
Clinical Evidence for Histoacryl® a n-butyl-2-cyanoacrylate tissue adhesive.
B. Braun Extranet >>
Профилактика повторного возникновения вентральных грыж при общих состояниях пациента (ожирение, диабет, аневризма брюшной аорты, инфицирование, рак)
[18] Primary closure of laparotomies with high risk of incisional hernia using prosthetic material: analysis of usefulness. C. Gutierrez de la Pena, C. Medina Achirica, E. Dominguez-Adame, J. Medina Diez. Hernia 2003; 7:134–136. Pubmed >>
[19] Estudio aleatorizado sobre la utilización de mallas reabsorbibles para la prevención de la evisceración en la cirugía colorrectal (Randomised study of the use resorbable Mesh for the prevention of evisceration in Colorectal surgery). F. de la Portilla, B. Flikier, E. Espinosa, A. Utrera, R. Rada, J. Vega, N. Cisneros, VH. Maldonado. Cir Esp. 2008; 83(1):12-7. (Article in Spanish). Pubmed >>