MonoMax for Abdominal Wall Closure

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01901068

Acronym

MULTIMAC

Enrollment

200

Registered

2013-07-17

Start date

2013-02-28

Completion date

2015-12-31

Last updated

2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Wall Wound

Keywords

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

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.

Interventions

DEVICEMonoMax

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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

Countries

Czechia, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026