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Primary Mesh Closure of Abdominal Midline Wounds (PRIMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00761475
Recruitment Status : Completed
First Posted : September 29, 2008
Last Update Posted : October 28, 2016
Baxter Healthcare Corporation
Aesculap AG
Information provided by (Responsible Party):
Hasan Eker, Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Incisional Hernia Occurence Procedure: mesh supported closure Procedure: primary closure Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Mesh Closure of Abdominal Midline Wounds; a Prospective Randomized Multicenter Trial
Study Start Date : February 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Placebo Comparator: 1
primary closure of the midline
Procedure: primary closure
primary closure of the midline

Active Comparator: 2
onlay mesh supported closure
Procedure: mesh supported closure
onlay mesh supported closure midline laparotomy

Active Comparator: 3
sublay mesh supported closure
Procedure: mesh supported closure
sublay mesh supported closure midline laparotomy

Primary Outcome Measures :
  1. incisional hernia occurence [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. complications [ Time Frame: 1 month ]
  2. post-operative pain [ Time Frame: 1 month ]
  3. quality of life [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00761475

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Vienna, Austria
Berlin-Charite Universitatsklinikum
Berlin, Germany
Hamburg-Eppefdorf Universitatsklinikum
Hamburg, Germany
Heidelberg University Medical Center
Heidelberg, Germany
Munchen University Medical Center
Munchen, Germany
Erasmus Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
IJsselland Ziekenhuis
Capelle a/d IJssel, Netherlands
Scheper Ziekenhuis
Emmen, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Sint Franciscus Gasthuis
Rotterdam, Netherlands
Maxima Medisch Centrum
Veldhoven, Netherlands
Isala klinieken
Zwolle, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
Baxter Healthcare Corporation
Aesculap AG
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Principal Investigator: J.F. Lange, Professor Erasmus Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hasan Eker, Prof. Dr. J.F. Lange, Erasmus Medical Center Identifier: NCT00761475    
Other Study ID Numbers: PRIMA TRIAL
First Posted: September 29, 2008    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Keywords provided by Hasan Eker, Erasmus Medical Center:
incisional hernia
Additional relevant MeSH terms:
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Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes