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Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management

This study has suspended participant recruitment.
(Because of the product recall 2005/2006.)
Sponsor:
Information provided by (Responsible Party):
PD Dr. Dr. Ulrich A. Dietz, University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT01520168
First received: January 24, 2012
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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
Incisional Hernia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • Early postoperative complications [ Time Frame: 6 months postoperative ] [ Designated as safety issue: Yes ]
    Assessment of postoperative complications (wound complication, mesh infection, seroma)


Secondary Outcome Measures:
  • Long-term postoperative complications [ Time Frame: 6 months to 5 years ] [ Designated as safety issue: Yes ]
    Chronic pain, chronic and recurrent mesh infection, mesh bulging, incisional hernia and intestinal fistula


Biospecimen Retention:   Samples Without DNA

Explanted meshes


Enrollment: 21
Study Start Date: October 2003
Estimated Study Completion Date: March 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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