NCT01901068|Completed
MonoMax for Abdominal Wall Closure
MULTIMAC
A Multicentre, International, Prospective Post-market Clinical Follow-up to Evaluate MonoMax for Abdominal Wall Closure
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MULTIMAC
A Multicentre, International, Prospective Post-market Clinical Follow-up to Evaluate MonoMax for Abdominal Wall Closure
Sponsor study identifier
observational
200
2 countries
3
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2015
Actual (reported)Study Completion
December 2015
Actual (reported)A great number of different suture techniques and suture materials are in use in order to reconstitute the abdominal wall integrity, but there is no surgical gold standard for abdominal wall closure until today. Various Meta-Analyses and randomized controlled trials have been performed, which compared non-absorbable or long-term absorbable versus rapid absorbable suture materials or monofilament versus multifilament suture materials, or continuous versus interrupted suture techniques respectively. This lack of evidence has the following outcome: burst abdomen is observed in 1-3% of patients within the first days after a laparotomy. The incidence of abdominal wall hernias 12 months postoperatively is estimated to be up to 20% (range 9 to 20%) . Wound infections develop in 3 to 21% of patients undergoing a median laparotomy within the first 30 days. At present most surgeons favour monofilament long-absorbable continuous sutures as the most suitable material for closing abdominal wounds after midline laparotomy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
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.
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 5, 2013
Actual (reported)July 17, 2013
Actual (reported)September 2015
Actual (reported)December 2015
Actual (reported)Frequency of reoperation due to burst abdomen
participants will be followed for the duration of hospital stay, an expected average of 10 days
Frequency of wound infections
participants will be followed for the duration of hospital stay, an expected average of 10 days
Incidence of wound healing until day of discharge
participants will be followed for the duration of hospital stay, an expected average of 10 days
Length of hospital stay
participants will be followed for the duration of hospital stay, an expected average of 10 days
Elective primary laparotomy
Abdominal wall will be closed with MonoMax after an elective primary laparotomy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
adult patients
Chirurgicka klinika, Fakultni nemocnine
Hradec Králové, 500 05, Czechia
Chirurgicka klinika, Fakultni nemocnine
Olomouc, 77520, Czechia
Central Emergency Military Hospital
Bucharest, Romania
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.
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.
200 participants (actual enrollment reported by the registry).
First Submitted
July 5, 2013
First Posted
July 17, 2013
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
Primary Completion
September 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
December 13, 2024
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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