Primary Mesh Closure of Abdominal Midline Wounds (PRIMA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Erasmus Medical Center
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Aesculap AG
Information provided by (Responsible Party):
hasan eker, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00761475
First received: September 26, 2008
Last updated: November 11, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Incisional Hernia Occurence
Procedure: mesh supported closure
Procedure: primary closure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Mesh Closure of Abdominal Midline Wounds; a Prospective Randomized Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • incisional hernia occurence [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complications [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • post-operative pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 460
Study Start Date: February 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761475

Contacts
Contact: L. Timmermans, MD 0031107034519 l.timmermans@erasmusmc.nl
Contact: H.H. Eker, MD 0031628925554 h.eker@erasmusmc.nl

Locations
Austria
Wilhelminenspital Recruiting
Vienna, Austria
Contact: R Fortelny, MD, PhD         
Principal Investigator: R Fortelny, MD, PhD         
Germany
Berlin-Charite Universitatsklinikum Recruiting
Berlin, Germany
Contact: P. Fikatas, MD       panagiotis.fikatas@charite.de   
Contact: P. Neuhaus, Professor       peter.neuhaus@charite.de   
Principal Investigator: P. Neuhaus, Professor         
Hamburg-Eppefdorf Universitatsklinikum Recruiting
Hamburg, Germany
Contact: A. Kutup, MD       kutup@uke.de   
Contact: J. Izbicki, Professor       izbicki@uke.de   
Principal Investigator: J. Izbicki, Professor         
Heidelberg University Medical Center Recruiting
Heidelberg, Germany
Contact: Ch M Seiler, MD, PhD         
Principal Investigator: Ch M Seiler, MD, PhD         
Munchen University Medical Center Recruiting
Munchen, Germany
Contact: A. Mihaljevic, MD       amihalje@googlemail.com   
Contact: C. Schumacher, Professor       Schuhmacher@chir.med.tu-muenchen.de   
Principal Investigator: C. Schumacher, Professor         
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Contact: L. Timmermans, MD    0031107034519    l.timmermans@erasmusmc.nl   
Contact: H.H. Eker, MD    0031628925554    h.eker@erasmusmc.nl   
Sub-Investigator: HH Eker, MD         
Principal Investigator: JF Lange, MD, Professor         
Sub-Investigator: L. Timmermans, MD         
IJsselland Ziekenhuis Recruiting
Capelle a/d IJssel, Netherlands
Contact: I Dawson, MD, PhD         
Principal Investigator: I Dawson, MD, PhD         
Scheper Ziekenhuis Recruiting
Emmen, Netherlands
Contact: M. van der Berg, MD, PhD       m.vanderberg@sze.nl   
Principal Investigator: M. van der Berg, MD, PhD         
Maasstad Ziekenhuis Recruiting
Rotterdam, Netherlands
Contact: P. Timmers, MD, PhD       TimmersP@maasstadziekenhuis.nl   
Principal Investigator: P. Timmers, MD, PhD         
Sint Franciscus Gasthuis Recruiting
Rotterdam, Netherlands
Contact: A vd Ham, MD, PhD         
Principal Investigator: A vd Ham, MD, PhD         
Maxima Medisch Centrum Recruiting
Veldhoven, Netherlands
Contact: J Charbon, MD, PhD         
Principal Investigator: J Charbon, MD, PhD         
Isala klinieken Recruiting
Zwolle, Netherlands
Contact: E.G.J.M. Pierik, MD,PhD       e.g.j.m.pierik@isala.nl   
Contact: S.S. Lases, MD       s.s.lases@isala.nl   
Principal Investigator: E.G.J.M. Pierik, MD,PhD         
Sponsors and Collaborators
Erasmus Medical Center
Baxter Healthcare Corporation
Aesculap AG
Investigators
Principal Investigator: J.F. Lange, Professor Erasmus Medical Center, Rotterdam
  More Information

No publications provided by Erasmus Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: hasan eker, Prof. Dr. J.F. Lange, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT00761475     History of Changes
Other Study ID Numbers: PRIMA TRIAL
Study First Received: September 26, 2008
Last Updated: November 11, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
incisional hernia

ClinicalTrials.gov processed this record on September 18, 2014