Ignite Creation Date:
2024-05-05 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00761475
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2008-09-26
Brief Title:
Primary Mesh Closure of Abdominal Midline Wounds
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Primary Mesh Closure of Abdominal Midline Wounds a Prospective Randomized Multicenter Trial
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMA
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 316 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None