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OpenTrials
Completed

NCT Number: NCT00761475

Primary Mesh Closure of Abdominal Midline Wounds

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wilhelminenspital, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mesh supported closure

Procedure

onlay mesh supported closure midline laparotomy

Primary closure

Procedure

primary closure of the midline

Primary outcomes

  1. incisional hernia occurence

    Time frame: 2 years

Secondary outcomes

  1. complications

    Time frame: 1 month

  2. post-operative pain

    Time frame: 1 month

  3. quality of life

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Aesculap AG
  • Baxter Healthcare Corporation

Registry information

Official study title

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

Acronym: PRIMA

Important dates

Study start
2009
Primary completion
2012
Study completion
2015
First posted
Sep 29, 2008
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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