Multi-center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax® for Abdominal Wall Closure

NCT00572507 | Completed

• 1 other identifier: AAG-G-H-0701
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

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. \[Knaebel HP et al., 2005\]

Conditions

Primary Median Laparotomy

Keywords

Absorbable Monofilament Suture Material; Safety and Efficacy; Abdominal Wall/ Fascia; Laparotomy

Outcome Measures

Primary Outcomes (1)

• frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy

  till day of discharge

Secondary Outcomes (1)

• 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

  different

Study Arms (1)

MonoMax

EXPERIMENTAL

MonoMax is used for abdominal wall closure

Device: MonoMax®

Interventions

MonoMax® DEVICE

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

Also known as: ultra-longterm-absorbable monofilament suture Aesculap MonoMax®

MonoMax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (4)

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

St. Bonifatius-Hospital; Chirurgische Klinik

Lingen, 49808, Germany

Location

Universitaetsklinikum Giessen-Marburg, Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie

Marburg, 35043, Germany

Location

Universitaetsklinikum Muenchen Grosshadern

München, 81377, Germany

Location

Related Publications (28)

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

  PMID: 1428925 BACKGROUND

• Eisner L, Harder F. [Incisional hernias]. Chirurg. 1997 Apr;68(4):304-9. doi: 10.1007/s001040050193. German.

  PMID: 9206624 BACKGROUND

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

  PMID: 1748022 BACKGROUND

• 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. doi: 10.1007/s002689900194.

  PMID: 8943179 BACKGROUND

• 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.

  PMID: 1675878 BACKGROUND

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

  PMID: 9446447 BACKGROUND

• Paul A, Korenkov M, Peters S, Fischer S, Holthausen U, Kohler 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. German.

  PMID: 9446448 BACKGROUND

• Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg. 2002 May;89(5):534-45. doi: 10.1046/j.1365-2168.2002.02083.x.

  PMID: 11972542 BACKGROUND

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

  PMID: 8681695 BACKGROUND

• 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. doi: 10.1136/bmj.2.6083.351.

  PMID: 329940 BACKGROUND

• Osther PJ, Gjode 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. doi: 10.1002/bjs.1800820824.

  PMID: 7648158 BACKGROUND

• 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.

  PMID: 2530745 BACKGROUND

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

  PMID: 6264641 BACKGROUND

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

  PMID: 8891617 BACKGROUND

• 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.

  PMID: 3931536 BACKGROUND

• 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. doi: 10.1002/bjs.1800740831.

  PMID: 3307992 BACKGROUND

• 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.

  PMID: 3111339 BACKGROUND

• 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. doi: 10.1046/j.1365-2168.2002.02258.x.

  PMID: 12390373 BACKGROUND

• 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. doi: 10.1007/s002689910120.

  PMID: 10773130 BACKGROUND

• 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. doi: 10.1097/00000658-200003000-00018.

  PMID: 10714638 BACKGROUND

• Weiland DE, Bay RC, Del Sordi S. Choosing the best abdominal closure by meta-analysis. Am J Surg. 1998 Dec;176(6):666-70. doi: 10.1016/s0002-9610(98)00277-3.

  PMID: 9926810 BACKGROUND

• Schumpelick V, Kingsanorth AN. Incisional Hernia. Questionnaire Survetta Meeting, March 1998: 496

  BACKGROUND

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

  BACKGROUND

• Knaebel HP, Koch M, Sauerland S, Diener MK, Buchler 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. doi: 10.1186/1471-2482-5-3.

  PMID: 15755324 BACKGROUND

• Fischer L, Baumann P, Husing J, Seidlmayer C, Albertsmeier M, Franck A, Luntz S, Seiler CM, Knaebel HP. 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]. BMC Surg. 2008 Jul 21;8:12. doi: 10.1186/1471-2482-8-12.

  PMID: 18644124 BACKGROUND

• Odermatt EK, Funk L, Bargon R, Martin DP, Rizk S, Williams SF. MonoMax Suture: A New Long-Term Absorbable Monofilament Suture Made from Poly-4-Hydroxybutyrate. International Journal of Polymer Science Volume 2012, Article ID 216137, 12 pages. doi:10.1155/2012/216137

  BACKGROUND

• Albertsmeier M, Seiler CM, Fischer L, Baumann P, Husing J, Seidlmayer C, Franck A, Jauch KW, Knaebel HP, Buchler MW. Evaluation of the safety and efficacy of MonoMax(R) suture material for abdominal wall closure after primary midline laparotomy-a controlled prospective multicentre trial: ISSAAC [NCT005725079]. Langenbecks Arch Surg. 2012 Mar;397(3):363-71. doi: 10.1007/s00423-011-0884-6. Epub 2011 Dec 20.

  PMID: 22183105 RESULT

• Fink C, Baumann P, Wente MN, Knebel P, Bruckner T, Ulrich A, Werner J, Buchler MW, Diener MK. Incisional hernia rate 3 years after midline laparotomy. Br J Surg. 2014 Jan;101(2):51-4. doi: 10.1002/bjs.9364. Epub 2013 Nov 26.

  PMID: 24281948 RESULT

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 13, 2007
• Study Start: December 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: July 1, 2009
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

DE (4)