MonoMax for Abdominal Wall Closure

Completed

• Conditions: Abdominal Wall Wound
• Interventions: Device: MonoMax

• Registration Number: NCT01901068
• Lead Sponsor: Aesculap AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-07-05
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-17
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MonoMax	MonoMax	Elective primary laparotomy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Chirurgicka klinika, Fakultni nemocnine; 🇨🇿 Olomouc, Czechia

Central Emergency Military Hospital; 🇷🇴 Bucharest, Romania