Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management
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|ClinicalTrials.gov Identifier: NCT01520168|
Recruitment Status : Suspended (Because of the product recall 2005/2006.)
First Posted : January 27, 2012
Last Update Posted : March 13, 2012
From its introduction in 2000 until its US recall in December 2005, the Composix Kugel Mesh was implanted in an estimated 350,000 patients worldwide.
The purpose of the study is to evaluate retrospectively the complications related to this mesh that occurred in our patients between 2003 and 2005, since new complications continue to be diagnosed, although the investigators discontinued the use of the mesh.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||The 2005 Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management: Taking Stock After 5-year Follow up|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||March 2012|
- Early postoperative complications [ Time Frame: 6 months postoperative ]Assessment of postoperative complications (wound complication, mesh infection, seroma)
- Long-term postoperative complications [ Time Frame: 6 months to 5 years ]Chronic pain, chronic and recurrent mesh infection, mesh bulging, incisional hernia and intestinal fistula
Biospecimen Retention: Samples Without DNA
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): NCT01520168
|Department of General, Visceral, Vascular and Pediatric Surgery|
|Wurzburg, Bavaria, Germany, 97080|
|Principal Investigator:||Ulrich A. Dietz, MD, PhD||University of Wuerzburg|