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A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects

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ClinicalTrials.gov Identifier: NCT01214252
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : December 20, 2012
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.

Condition or disease Intervention/treatment
Abdominal Wall Defects Device: Permacol Surgical Implant

Study Design

Study Type : Observational
Actual Enrollment : 343 participants
Time Perspective: Retrospective
Study Start Date : October 2010
Primary Completion Date : September 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Permacol Patients
Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
Device: Permacol Surgical Implant
Permacol Surgical Implant


Outcome Measures

Primary Outcome Measures :
  1. Confirmed Hernia Recurrence [ Time Frame: 12 months ]
    Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review


Secondary Outcome Measures :
  1. Total Unconfirmed Hernia or Hernia Recurrence [ Time Frame: 12 Months ]

    Total unconfirmed hernia or hernia recurrence at the repair site by year (Number and percentage)

    Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms Questionniare but not confirmed by clinical assessment by a surgeon or medical chart review


  2. Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed [ Time Frame: Year 2 to Year 8 ]
    Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed


Eligibility Criteria

Information from the National Library of Medicine

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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
Patients who have undergone surgical repair of their abdominal wall defects with Permacol Surgical Implants with at least 12 months(-30days)follow-up
Criteria

Inclusion Criteria:

  • Equal or over 18 years of age
  • Had undergone surgical repair or reconstruction of abdominal wall defects, ventral hernias or incisional hernias using Permacol Surgical Implant.
  • At least 12 months of follow-up post date of surgery (-30 days)
  • Undergone open or laparoscopic repairs

Exclusion Criteria:

  • Had undergone inguinal, parastomal, diaphragmatic or paraesophageal/hiatal hernia repair
  • Any prior use of Permacol in abdominal wall repair
Contacts and Locations

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): NCT01214252


Locations
United States, Massachusetts
Annie Choi
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
Medtronic - MITG
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01214252     History of Changes
Other Study ID Numbers: COVPERH0046
First Posted: October 5, 2010    Key Record Dates
Results First Posted: December 20, 2012
Last Update Posted: May 9, 2014
Last Verified: April 2014

Keywords provided by Medtronic - MITG:
Repair of patients' abdominal wall defects