MonoMax for Abdominal Wall Closure

Abdominal Wall Wound Clinical Trial

— MULTIMAC  

Official title:

A Multicentre, International, Prospective Post-market Clinical Follow-up to Evaluate MonoMax for Abdominal Wall Closure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901068
• Other study ID #: AAG-O-H-1010
• Status: Completed
• Phase: N/A
• First received: July 5, 2013
• Last updated: February 9, 2016
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics CommitteeRomania: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years and older

• Elective primary laparotomy

• Written informed consent

Exclusion Criteria:

• Peritonitis

• Emergency surgery

• Severe psychiatric and neurologic disease

• Drug- and / or alcohol abuse according to local standard

• Lack of informed consent

• Current immunosuppressive therapy

• Chemotherapy within the 2 weeks before operation

• Radiotherapy of the abdomen completed less than 8 before surgery

• Pregnant or breast-feeding women

• Coagulopathy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Wall Wound

Intervention

Device:
• MonoMax
Abdominal wall will be closed with MonoMax after an elective primary laparotomy.

Locations

Country	Name	City	State
Czech Republic	Chirurgicka klinika, Fakultni nemocnine	Hradec Kralove
Czech Republic	Chirurgicka klinika, Fakultni nemocnine	Olomouc
Romania	Central Emergency Military Hospital	Bucharest

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Countries where clinical trial is conducted

Czech Republic,  Romania, 

References & Publications (3)

Albertsmeier M, Seiler CM, Fischer L, Baumann P, Hüsing J, Seidlmayer C, Franck A, Jauch KW, Knaebel HP, Büchler MW. Evaluation of the safety and efficacy of MonoMax® 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. — View Citation

Fink C, Baumann P, Wente MN, Knebel P, Bruckner T, Ulrich A, Werner J, Büchler 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. — View Citation

Fischer L, Baumann P, Hüsing 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of reoperation due to burst abdomen		participants will be followed for the duration of hospital stay, an expected average of 10 days	Yes
Primary	Frequency of wound infections		participants will be followed for the duration of hospital stay, an expected average of 10 days	Yes
Secondary	Incidence of wound healing until day of discharge		participants will be followed for the duration of hospital stay, an expected average of 10 days	No
Secondary	Length of hospital stay		participants will be followed for the duration of hospital stay, an expected average of 10 days	No