Multi-Center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax® for Abdominal Wall Closure - Full Text View

Purpose

MonoMax will be used for a continuous all-layer (except skin) suture to close abdominal wall after midline incision. The primary objective of this trial is to demonstrate that the frequency of wound infection and the frequency of reoperation due to burst-abdomen after primary median laparotomy for elective surgical intervention are equal or lower than in the INSECT trial. The secondary objectives are to demonstrate that the length of postoperative hospital stay and the frequency of abdominal hernias 12 months after the surgery are equal or lower than in the INSECT trial. [Knaebel HP et al., 2005]

Condition	Intervention
Primary Median Laparotomy	Device: MonoMax®

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Historically-Controlled Single-Arm Multi-Center Prospective Trial to Evaluate the Safety and Efficacy of Aesculap MonoMax® Suture Material for Abdominal Wall Closure After Primary Median Laparotomy

Further study details as provided by Aesculap AG & Co. KG:

Primary Outcome Measures:

frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy [ Time Frame: till day of discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

length of postoperative hospital stay after surgery and frequency of incisional hernias 12 months after the surgery and frequency of wound infections 30 days postoperative [ Time Frame: different ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2009

Intervention Details:

Abdominal wall closure with ultra-longterm absorbable monofilament suture after primary median laparotomy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age equal or greater than 18 years
Expected survival time > 12 months
Patient undergoing elective and primary median laparotomy
BMI < 35
Expected length of skin incision > 15 cm

Exclusion Criteria:

Peritonitis
Emergency surgery
Coagulopathy
Current immunosuppressive therapy (> 40 mg of a Corticoid per day or Azathioprin)
Chemotherapy within 2 weeks before operation
Radiotherapy of the abdomen completed less than 8 weeks before operation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572507

Contacts


Contact: Baerbel Kaestner, Dr.	+49-6221-56-0 ext 38218	baerbel.kaestner@med.uni-heidelberg.de

Contact: Petra Baumann, Dr.	+49-7461-95-0 ext 1646	petra.baumann@aesculap.de

Locations


Germany
	Universitaetsklinikum Heidelberg	Recruiting
	Heidelberg, Germany, 69120
	Principal Investigator: Markus W Buechler, Prof. Dr.
	Universitaetsklinikum Muenchen Grosshadern	Recruiting
	Muenchen, Germany, 81377
	Principal Investigator: Karl-Walter Jauch, Prof. Dr.
	Universitaetsklinikum Giessen-Marburg, Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie	Recruiting
	Marburg, Germany, 35043
	Principal Investigator: Annette Franck, Dr.
	St. Bonifatius-Hospital; Chirurgische Klinik	Recruiting
	Lingen, Germany, 49808
	Principal Investigator: Christoph Seidlmayer, Dr.

Sponsors and Collaborators

Aesculap AG & Co. KG

Investigators


Principal Investigator:	Markus W Buechler, Prof. Dr.	Universitaetsklinikum Heidelberg; Chirugische Klinik

Principal Investigator:	Karl-Walter Jauch, Prof. Dr.	Klinikum der Universitaet Muenchen, Grosshadern; Chirurgische Klinik und Poliklinik

Principal Investigator:	Annette Franck, Dr.	Universitaets-Klinikum Giessen-Marburg; Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie

Principal Investigator:	Christoph Seidlmayer, Dr.	St. Bonifatius Hospital, Lingen

More Information

Publications:

Amgwerd M, Decurtins M, Largiadèr F. [Hernia of the surgical scar--predisposition or inadequate suture technique?] Helv Chir Acta. 1992 Aug;59(2):345-8. German. No abstract available.

Eisner L, Harder F. [Incisional hernias] Chirurg. 1997 Apr;68(4):304-9. Review. German.

Zimmermann G, Müller G, Haid A. [Surgical therapy of incisional hernias] Chirurg. 1991 Sep;62(9):656-62. Review. German. No abstract available.

Luijendijk RW, Lemmen MH, Hop WC, Wereldsma JC. Incisional hernia recurrence following "vest-over-pants" or vertical Mayo repair of primary hernias of the midline. World J Surg. 1997 Jan;21(1):62-5; discussion 66.

Manninen MJ, Lavonius M, Perhoniemi VJ. Results of incisional hernia repair. A retrospective study of 172 unselected hernioplasties. Eur J Surg. 1991 Jan;157(1):29-31.

Paul A, Lefering R, Köhler L, Eypasch E. [Current practice of incisional hernia reconstruction in Germany] Zentralbl Chir. 1997;122(10):859-61. German.

Paul A, Korenkov M, Peters S, Fischer S, Holthausen U, Köhler L, Eypasch E. [Mayo duplication in treatment of incisional hernia of the abdominal wall after conventional laparotomy. Results of a retrospective analysis and comparison with the literature] Zentralbl Chir. 1997;122(10):862-70. Review. German.

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

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.

Irvin TT, Stoddard CJ, Greaney MG, Duthie HL. Abdominal wound healing: a prospective clinical study. Br Med J. 1977 Aug 6;2(6083):351-2.

Osther PJ, Gjøde P, Mortensen BB, Mortensen PB, Bartholin J, Gottrup F. Randomized comparison of polyglycolic acid and polyglyconate sutures for abdominal fascial closure after laparotomy in patients with suspected impaired wound healing. Br J Surg. 1995 Aug;82(8):1080-2.

Gys T, Hubens A. A prospective comparative clinical study between monofilament absorbable and non-absorbable sutures for abdominal wall closure. Acta Chir Belg. 1989 Sep-Oct;89(5):265-70.

Bucknall TE, Ellis H. Abdominal wound closure--a comparison of monofilament nylon and polyglycolic acid. Surgery. 1981 Jun;89(6):672-7.

Israelsson LA, Jonsson T, Knutsson A. Suture technique and wound healing in midline laparotomy incisions. Eur J Surg. 1996 Aug;162(8):605-9.

Leaper DJ, Allan A, May RE, Corfield AP, Kennedy RH. Abdominal wound closure: a controlled trial of polyamide (nylon) and polydioxanone suture (PDS). Ann R Coll Surg Engl. 1985 Sep;67(5):273-5.

Wissing J, van Vroonhoven TJ, Schattenkerk ME, Veen HF, Ponsen RJ, Jeekel J. Fascia closure after midline laparotomy: results of a randomized trial. Br J Surg. 1987 Aug;74(8):738-41.

Cameron AE, Parker CJ, Field ES, Gray RC, Wyatt AP. A randomised comparison of polydioxanone (PDS) and polypropylene (Prolene) for abdominal wound closure. Ann R Coll Surg Engl. 1987 May;69(3):113-5.

van 't Riet M, Steyerberg EW, Nellensteyn J, Bonjer HJ, Jeekel J. Meta-analysis of techniques for closure of midline abdominal incisions. Br J Surg. 2002 Nov;89(11):1350-6.

Hsiao WC, Young KC, Wang ST, Lin PW. Incisional hernia after laparotomy: prospective randomized comparison between early-absorbable and late-absorbable suture materials. World J Surg. 2000 Jun;24(6):747-51; discussion 752.

Hodgson NC, Malthaner RA, Ostbye T. The search for an ideal method of abdominal fascial closure: a meta-analysis. Ann Surg. 2000 Mar;231(3):436-42.

Weiland DE, Bay RC, Del Sordi S. Choosing the best abdominal closure by meta-analysis. Am J Surg. 1998 Dec;176(6):666-70.

Knaebel HP, Koch M, Sauerland S, Diener MK, Büchler MW, Seiler CM; INSECT Study Group of the Study Centre of the German Surgical Society. Interrupted or continuous slowly absorbable sutures - design of a multi-centre randomised trial to evaluate abdominal closure techniques INSECT-trial [ISRCTN24023541]. BMC Surg. 2005 Mar 8;5:3.

Responsible Party:	Aesculap AG & Co. KG ( Dr. Hanns-Peter Knaebel )
Study ID Numbers:	AAG-G-H-0701
First Received:	December 11, 2007
Last Updated:	March 13, 2008
ClinicalTrials.gov Identifier:	NCT00572507
Health Authority:	Germany: German Institute of Medical Documentation and Information

Keywords provided by Aesculap AG & Co. KG:

Absorbable Monofilament Suture Material

Safety and Efficacy

Abdominal Wall/ Fascia

Laparotomy

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Aesculap AG & Co. KG
Information provided by:	Aesculap AG & Co. KG
ClinicalTrials.gov Identifier:	NCT00572507