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MonoMax for Abdominal Wall Closure

NCT ID: NCT01901068

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominal Wall Wound

Keywords

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Laparotomy Surgical Procedures, Elective Sutures Abdominal Wound Closure Techniques

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MonoMax

Elective primary laparotomy

MonoMax

Intervention Type DEVICE

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

Interventions

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MonoMax

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B.Braun Surgical SA

INDUSTRY

Sponsor Role collaborator

Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chirurgicka klinika, Fakultni nemocnine

Hradec Králové, , Czechia

Site Status

Chirurgicka klinika, Fakultni nemocnine

Olomouc, , Czechia

Site Status

Central Emergency Military Hospital

Bucharest, , Romania

Site Status

Countries

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Czechia Romania

References

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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.

Reference Type BACKGROUND
PMID: 24281948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18644124 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22183105 (View on PubMed)

Other Identifiers

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AAG-O-H-1010

Identifier Type: -

Identifier Source: org_study_id