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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
Sponsor:
Information provided by (Responsible Party):
PD Dr. Dr. Ulrich A. Dietz, University of Wuerzburg

Brief Summary:

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
Incisional Hernia

Detailed Description:
From 2003 to 2005(2006) we implanted Komposix Kugel Meshes in 21 Patients with incisional ventral hernias. With the recall of January 2006 (in Germany), we stopped the implantation of this mesh and continued to monitor the patients with follow up and phone interviews. Late complications still continue to occur, mainly as a consequence of the product defect identified 7 years ago.

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources




Primary Outcome Measures :
  1. Early postoperative complications [ Time Frame: 6 months postoperative ]
    Assessment of postoperative complications (wound complication, mesh infection, seroma)


Secondary Outcome Measures :
  1. 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
Explanted meshes


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (>18 years) with the diagnosis of symptomatic incisional hernia.
Criteria

Inclusion Criteria:

  • Age > 18
  • Incisional hernia

Exclusion Criteria:

  • Younger than 18 years
  • Peritonitis
  • Intestinal fistula

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 ClinicalTrials.gov identifier (NCT number): NCT01520168


Locations
Germany
Department of General, Visceral, Vascular and Pediatric Surgery
Wurzburg, Bavaria, Germany, 97080
Sponsors and Collaborators
University of Wuerzburg
Investigators
Principal Investigator: Ulrich A. Dietz, MD, PhD University of Wuerzburg

Publications:
Responsible Party: PD Dr. Dr. Ulrich A. Dietz, PD Dr. Dr., University of Wuerzburg
ClinicalTrials.gov Identifier: NCT01520168     History of Changes
Other Study ID Numbers: UD 069/11
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by PD Dr. Dr. Ulrich A. Dietz, University of Wuerzburg:
Incisional hernia
Mesh
Surgery
Composix Kugel
IPOM technique

Additional relevant MeSH terms:
Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes