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Clinical Evidence

Abdominal Wall Indication Products Studies
Abdominal
Wall Closure
Laparotomy Closure Monomax®
MonoPlus®

INSECT [01], [02],
[03], [04], [05]
and
ISSAAC [06]

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Abdominal
Wall
Hernia
Repair
and
Recurrent

Inguinal Open:
Lichtenstein

Rutkow-Robbins

Inguinal Lap:
TAPP/TEP

Incisional Open:
Onlay/Sublay
  

Incisional Lap/Open:
IPOM

Optilene® Mesh
Optilene® Mesh LP

Premilene® Mesh Plug

Optilene® Mesh
Optilene® Mesh LP

Optilene® Mesh
Optilene® Mesh Elastic
Premilene® Mesh

Omyra® Mesh
  

Prevention of
Chronic Pain [10]
and
Best Mesh-Glue
combination
for Fixation [07]
and
Biocompatibility
Tissue Integration
[08], [09]

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Mesh Fixation

 Mesh Fixation in 
Inguinal open: Lichtenstein

 

 

 

 

Mesh fixation in
Inguinal Laparoscopy:
TAPP/TEP
   

Histoacryl®
combined with
Vipro II

 

 

 

 

Histoacryl®
combined with
Vipro II,
Timesh & Ultrapro 

Sutureless Lichtenstein:
First results of a prospective
randomised clinical trial

Prospective randomized
trial comparing sutured
with sutureless mesh
fixation for Lichtenstein
hernia repair: long-term results.

Efficiency and safety of
mesh fixation in laparoscopic
inguinal hernia repair using n-butyl
cyanoacrylate:
long-term biocompatibility
in over 1,300 mesh
fixations [15], [16], [17]

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 Abdominal
Wall
Defects
Prevention
Laparotomy in
risk patients:
Obese, Diabetic,
AAA, HTA, Infected,
Collagen, Cancer 
 Monomax®
combined with
Optilene® Mesh Elastic or
Optilene® Mesh LP
or
Safil® Mesh

Prophylactic
Mesh in Cancer
Patients [18], [19]

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1Abdominal Wall Closure – 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

1Hernia Repair – 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

Hernia Repair – 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

Hernia Repair – 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.

1Mesh Fixation – 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

Incisional Hernia Prevention in high risk Patients

[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