CClinicalTrials.gg
CompletedNCT01901068MULTIMACUpdated Dec 13, 2024

MonoMax for Abdominal Wall Closure

An observational study in Abdominal Wall Wound, sponsored by Aesculap AG. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-13.

Sponsored by Aesculap AG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Abdominal Wall Wound

Keywords

  • Laparotomy
  • Surgical Procedures, Elective
  • Sutures
  • Abdominal Wound Closure Techniques
03

In context

Lead sponsor

Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adult patients

Inclusion criteria

  • Age 18 years and older
  • Elective primary laparotomy
  • Written informed consent

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • MonoMax

    Elective primary laparotomy

    Device: MonoMax

Interventions

  • DeviceMonoMax

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

06

What researchers measure

Primary outcomes

  1. Frequency of reoperation due to burst abdomen

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

  2. Frequency of wound infections

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary outcomes

  1. Incidence of wound healing until day of discharge

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

  2. Length of hospital stay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

07

Study locations

3 sites
  • Chirurgicka klinika, Fakultni nemocnine
    Hradec Kralove, 500 05, Czechia
  • Chirurgicka klinika, Fakultni nemocnine
    Olomouc, 77520, Czechia
  • Central Emergency Military Hospital
    Bucharest, Romania
08

References and documents

Publications

  • 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. PubMed 24281948 ↗
  • 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. PubMed 18644124 ↗
  • 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. PubMed 22183105 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01901068
Lead sponsor
Aesculap AG
Collaborators
B.Braun Surgical SA
Responsible party
Sponsor
First posted
Jul 17, 2013
Start date
Feb 2013
Primary completion
Sep 2015
Completion
Dec 2015
Last update
Dec 13, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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