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Primary Mesh Closure of Abdominal Midline Wounds

Primary Mesh Closure of Abdominal Midline Wounds; a Prospective Randomized Multicenter Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00761475
Acronym
PRIMA
Enrollment
480
Registered
2008-09-29
Start date
2009-02-28
Completion date
2015-04-30
Last updated
2016-10-28

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

Conditions

Incisional Hernia Occurence

Keywords

incisional hernia

Brief summary

Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Major risk factors for incisional hernia after a laparotomy, like obesity, steroid use, malnutrition, smoking and connective tissue disorders, are known. Despite this knowledge, there has not yet been developed a sufficient method for prevention. One specific group of high risk patients are patients with an abdominal aortic aneurysm (AAA). The relationship between aortic aneurysm and other abdominal wall hernias, like inguinal hernias, has been reported. Retrospective and prospective studies have shown an average risk for incisional hernia after AAA repair of 31.6 %. Another high risk group is the group of obese patients. Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. Considering only 50 % of incisional hernia will be clinically evident in the first 12 months, the total incidence will be above 30%. This high risk group of patients with obesitas and aneurysmatic disease can benefit most from prevention. Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomal surgery. However, there has not been performed an adequate randomized controlled trial to study the prevention of incisional hernias. Our hypothesis is that incisional hernia prevention with use of prosthetic mesh after laparotomy is effective in patients with aortic aneurysm and in obese patients with a BMI of more than 27.

Interventions

PROCEDUREmesh supported closure

onlay mesh supported closure midline laparotomy

primary closure of the midline

Sponsors

Baxter Healthcare Corporation
CollaboratorINDUSTRY
Aesculap AG
CollaboratorINDUSTRY
Erasmus Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Every elective midline laparotomy for patients with Abdominal Aortic Aneurysm and patients with a BMI of more than 27. * Signed informed consent

Exclusion criteria

* Age \< 18 years * Emergency procedure * Inclusion in other trials * Aortic reconstruction for obstructive disease * Life expectancy less than 24 months * Pregnant women

Design outcomes

Primary

MeasureTime frame
incisional hernia occurence2 years

Secondary

MeasureTime frame
complications1 month
post-operative pain1 month
quality of life2 years

Countries

Austria, Germany, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026