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

Abdominal Wall Defects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214252
• Other study ID #: COVPERH0046
• Status: Completed
• Phase: N/A
• First received: September 30, 2010
• Last updated: April 8, 2014
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: April 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardEuropean Union: European Medicines AgencyNational Competent Authorities (NCAs) of EU Member states: UK
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: January 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Abdominal Wall Defects

Intervention

Device:
• Permacol Surgical Implant
Permacol Surgical Implant

Locations

Country	Name	City	State
United States	Annie Choi	Bedford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed Hernia Recurrence	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	12 months	Yes
Secondary	Total Unconfirmed Hernia or Hernia Recurrence	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	12 Months	Yes
Secondary	Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed	Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed	Year 2 to Year 8	Yes