Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair

Incisional Hernia Repair Clinical Trial

— Optilene  

Official title:

A Randomised, Multi-center, Prospective, Observer and Patient Blind Study to Evaluate AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646334
• Other study ID #: AAG-G-H-0505
• Status: Completed
• Phase: N/A
• First received: March 18, 2008
• Last updated: May 27, 2015
• Start date: June 2006
• Est. completion date: September 2010

Study information

• Verified date: May 2015
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Optilene® Mesh Elastic and Ultrapro® Mesh will be used for incisional hernia repair. The primary objective of this clinical study is to demonstrate that Optilene® Mesh Elastic is superior to Ultrapro® Mesh in incisional hernia repair in matter of the physical function score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the patient's daily activity, the rating of patients pain and the wound assessment determined on several occasions during the six months observation time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female or male patients >=18 years

• Female patients are incapable of pragnancy or must be using adequate contraception and are not in lactation

• Patients wiht vertical aponeurotic incisions only

• Incisional hernia with hernia size >= 3 cm

• Patient is capable to understand and to follow the instructions

• written informed consent

• no mesh implantation at the same site during a previous operation

• immune competence of patient

Exclusion Criteria:

• Simultanous participation in an investigational drug or medical device study

• Patients < 18 years old

• Incisional Hernia withe a hernia size < 3 cm

• Repair of an acute incarcerated hernia

• Previous mesh repair at the same site

• Patient with other than vertical aponeurotic incisions

• Enterotomy to be performed during hernia repair at Surgery

• Patient is on anti-coagulations-therapy

• Patient is known or assessed to be non-compliant

• Additional surgical treatment at the same time (e.g. cholecystectomy)

• Immune incompetence of patient (e.g. chemotherapy)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia Repair

Intervention

Device:
• Mesh Implantation
An elective incisional Hernia repair is performed by using Optilene® Mesh Elastic, a lightweight and large pore mesh, knitted from monofilament polypropylene. Due to the multidirectional elasticity the mesh is able to adapt to all movements taking place in the abdominal wall.
• Mesh Implantation
Ultrapro® Mesh is a knitted, partly absorbable, lightweight mesh, consisting of equal parts of nonabsorbable polypropylene and absorbable polyglecaprone (Monocryl®). Polyglecaprone is fully absorbed in the body by hydrolysis. The addition of polyglecapron filament is only intended to reinforce the mesh to allow a convenient intraoperative handling and mesh placement, without additional function. Ultrapro® is an elastic mesh having enlarged elasticity cross to the blue strips.

Locations

Country	Name	City	State
Germany	Klinikum Aschaffenburg	Aschaffenburg	Bayern
Germany	Andreas Kuthe	Hannover	Niedersachsen
Germany	Krankenhaus Salem	Heidelberg	Baden-Wuerttemberg
Germany	Universitaetsklinikum Heidelberg	Heidelberg	Baden-Wuerttemberg
Germany	Universitaetsklinikum Mannheim	Mannheim	Baden-Wuerttemberg
Germany	Albert-Schweitzer Krankenhaus	Northeim	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

References & Publications (13)

Beets GL, Go PM, van Mameren H. Foreign body reactions to monofilament and braided polypropylene mesh used as preperitoneal implants in pigs. Eur J Surg. 1996 Oct;162(10):823-5. — View Citation

Benhidjeb T, Baerlehner E, Anders S. Laparoskopische Narbenhernien Reparation: Muss das Netz fuer die Intraperitoneale Onlay-Mesh-Technik besondere Eigenschaften haben?; Chir. Gastroenterol. 2003; 19(Suppl.2): 16-22

Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg. 2002 May;89(5):534-45. Review. — View Citation

Klinge U, Conze J, Klosterhalfen B, Limberg W, Obolenski B, Ottinger AP, Schumpelick V. [Changes in abdominal wall mechanics after mesh implantation. Experimental changes in mesh stability]. Langenbecks Arch Chir. 1996;381(6):323-32. German. — View Citation

Klinge U, Conze J, Limberg W, Brücker C, Ottinger AP, Schumpelick V. [Pathophysiology of the abdominal wall]. Chirurg. 1996 Mar;67(3):229-33. Review. German. — View Citation

Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze J, Schumpelick V. Impact of polymer pore size on the interface scar formation in a rat model. J Surg Res. 2002 Apr;103(2):208-14. — View Citation

Rickert A, Kienle P, Kuthe A, Baumann P, Engemann R, Kuhlgatz J, von Frankenberg M, Knaebel HP, Büchler MW. A randomised, multi-centre, prospective, observer and patient blind study to evaluate a non-absorbable polypropylene mesh vs. a partly absorbable m — View Citation

Rosch R, Junge K, Stumpf M, Klinge U, Schumpelick V, Klosterhalfen B; Welche Anforderungen sollte ein ideales Netz erfuellen?; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 7-11

Rosen HR, Gyasi A; Retromuskulaere Kunststoffnetzimplantation von Narbenhernien; Chir. Gastroenterol.; 2003; 19 (Suppl. 2); 39-45

Schumpelick V, Arlt G, Klinge U. [Versorgung von Nabelhernien und Narbenhernien]. Dt. Aerzteblatt 94, Heft 51-52. Dez. 1997 (35)

Schumpelick V, Lloyd M. Meshes: benefits and risks, 9 Polypropylene: The standard of Mesh Materials. Nyhus Editors, Springer Verlag, 2004: 101-103

Schumpelick V, van Ackeren H, Klinge U; Hernien; Thieme Verlag, 2000; 266-267

Seiler C, Baumann P, Kienle P, Kuthe A, Kuhlgatz J, Engemann R, V Frankenberg M, Knaebel HP. A randomised, multi-centre, prospective, double blind pilot-study to evaluate safety and efficacy of the non-absorbable Optilene Mesh Elastic versus the partly absorbable Ultrapro Mesh for incisional hernia repair. BMC Surg. 2010 Jul 12;10:21. doi: 10.1186/1471-2482-10-21. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical function score of the SF-36 questionnaire		21 days after insertion	No
Secondary	physical function score from the SF-36 questionnaire		6 months postoperatively	No
Secondary	patient's daily activity		6 months postoperatively	No
Secondary	patient's pain		6 months postoperatively	No
Secondary	wound assessment		6 months postoperatively	No