ISSAAC
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
Sponsor study identifier
interventional
150
1 country
4
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2008
Actual (reported)Study Completion
July 2009
Actual (reported)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. \[Knaebel HP et al., 2005\]
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 11, 2007
Actual (reported)December 13, 2007
Actual (reported)August 2008
Actual (reported)July 2009
Actual (reported)frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy
till day of discharge
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
MonoMax is used for abdominal wall closure
Abdominal wall closure with ultra-longterm absorbable monofilament suture after primary median laparotomy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
St. Bonifatius-Hospital; Chirurgische Klinik
Lingen, 49808, Germany
Universitaetsklinikum Giessen-Marburg, Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie
Marburg, 35043, Germany
Universitaetsklinikum Muenchen Grosshadern
München, 81377, Germany
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.
Eisner L, Harder F. [Incisional hernias]. Chirurg. 1997 Apr;68(4):304-9. doi: 10.1007/s001040050193. German.
Zimmermann G, Muller G, Haid A. [Surgical therapy of incisional hernias]. Chirurg. 1991 Sep;62(9):656-62. No abstract available. German.
Markus W Buechler, Prof. Dr.
Universitaetsklinikum Heidelberg; Chirugische Klinik
Karl-Walter Jauch, Prof. Dr.
Klinikum der Universitaet Muenchen, Grosshadern; Chirurgische Klinik und Poliklinik
Annette Franck, Dr.
Universitaets-Klinikum Giessen-Marburg; Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie
Christoph Seidlmayer, Dr.
St. Bonifatius Hospital, Lingen
150 participants (actual enrollment reported by the registry).
First Submitted
December 11, 2007
First Posted
December 13, 2007
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
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, Kohler 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, 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.
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.
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.
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.
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.
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. doi: 10.1002/bjs.1800740831.
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. doi: 10.1046/j.1365-2168.2002.02258.x.
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.
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.
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.
Schumpelick V, Kingsanorth AN. Incisional Hernia. Questionnaire Survetta Meeting, March 1998: 496
Schumpelick V, Arlt G, Klinge U. Versorgung von Nabelhernien und Narbenhernien. Dt. Aerzteblatt 94, 51-52. Dez. 1997 (35)
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.
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.
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
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.
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.
Primary Completion
August 2008
Actual (reported)Study Completion
July 2009
Actual (reported)Last Updated
May 28, 2015
Record last verified: 2015-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: