A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects
This study has been completed.
Information provided by (Responsible Party):
First received: September 30, 2010
Last updated: December 19, 2012
Last verified: December 2012
To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.
|Study Design:||Time Perspective: Retrospective|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Covidien:
Primary Outcome Measures:
- Confirmed Hernia Recurrence [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair siste. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon
- Confirmed and Unconfirmed Hernias/Hernia Recurrences [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Unconfirmed Hernia or Hernia Recurrence [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]Unconfirmed 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 reported by the patient is defined by confirmation of heria symptoms based on the Symptoms Questionnaire, but not confirmed by clinical assessment by surgeon.
|Study Start Date:||October 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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
Contacts and Locations