Skip to main content
OpenTrials
Completed

NCT Number: NCT01214252

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abdominal Wall Defects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Annie Choi

Bedford, Massachusetts, 01730, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Permacol Surgical Implant

Device

Permacol Surgical Implant

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 5, 2010
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.