Primary Mesh Closure of Abdominal Midline Wounds (PRIMA)
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ClinicalTrials.gov Identifier: NCT00761475 |
Recruitment Status :
Completed
First Posted : September 29, 2008
Last Update Posted : October 28, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Incisional Hernia Occurence | Procedure: mesh supported closure Procedure: primary closure | Phase 3 |
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 |
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
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Procedure: mesh supported closure
sublay mesh supported closure midline laparotomy |
- incisional hernia occurence [ Time Frame: 2 years ]
- complications [ Time Frame: 1 month ]
- post-operative pain [ Time Frame: 1 month ]
- quality of life [ Time Frame: 2 years ]

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00761475
Austria | |
Wilhelminenspital | |
Vienna, Austria | |
Germany | |
Berlin-Charite Universitatsklinikum | |
Berlin, Germany | |
Hamburg-Eppefdorf Universitatsklinikum | |
Hamburg, Germany | |
Heidelberg University Medical Center | |
Heidelberg, Germany | |
Munchen University Medical Center | |
Munchen, Germany | |
Netherlands | |
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 |
Principal Investigator: | J.F. Lange, Professor | Erasmus Medical Center |
Responsible Party: | Hasan Eker, Prof. Dr. J.F. Lange, Erasmus Medical Center |
ClinicalTrials.gov 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 |
incisional hernia |
Hernia Incisional Hernia Pathological Conditions, Anatomical Postoperative Complications Pathologic Processes |