Clinical trial NCT01901068: MonoMax for Abdominal Wall Closure
Official title: A Multicentre, International, Prospective Post-market Clinical Follow-up to Evaluate MonoMax for Abdominal Wall Closure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Wall Wound
Keywords: Laparotomy
Surgical Procedures, Elective
Sutures
Abdominal Wound Closure Techniques
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2013-07-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of reoperation due to burst abdomen
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: Frequency of wound infections
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes:
measure: Incidence of wound healing until day of discharge
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: Length of hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: Chirurgicka klinika, Fakultni nemocnine
city: Olomouc
country: Czechia
facility: Chirurgicka klinika, Fakultni nemocnine
city: Bucharest
country: Romania
facility: Central Emergency Military Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.