Trial Outcomes & Findings for A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects (NCT NCT01214252)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

343 participants

Primary outcome timeframe

12 months

Results posted on

2014-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Permacol Patients Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
Overall Study STARTED	425
Overall Study COMPLETED	343
Overall Study NOT COMPLETED	82

Reasons for withdrawal

Reasons for withdrawal
Measure	Permacol Patients Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
Overall Study Not eligible per protocol	82

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Permacol Patients n=343 Participants Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	236 Participants n=99 Participants
Age, Categorical >=65 years	107 Participants n=99 Participants
Age, Continuous	57.1 years STANDARD_DEVIATION 14.0 • n=99 Participants
Sex: Female, Male Female	162 Participants n=99 Participants
Sex: Female, Male Male	181 Participants n=99 Participants
Region of Enrollment Europe	109 participants n=99 Participants
Region of Enrollment United States	234 participants n=99 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Permacol Patients n=343 Participants Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up. Permacol Surgical Implant: Permacol Surgical Implant
Confirmed Hernia Recurrence	20 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Permacol Patients n=343 Participants Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up. Permacol Surgical Implant: Permacol Surgical Implant
Total Unconfirmed Hernia or Hernia Recurrence	9 participants

SECONDARY outcome

Timeframe: Year 2 to Year 8

Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed

Outcome measures

Outcome measures
Measure	Permacol Patients n=343 Participants Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up. Permacol Surgical Implant: Permacol Surgical Implant
Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed Year 2- out of 320 pts	26 participants
Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed Year 3- out of 133 pts	19 participants
Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed Year 4- out of 67 pts	5 participants
Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed Year 5- out of 25 pts	4 participants
Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed Year 6- out of 13 pts	1 participants
Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed Year 7- out of 6 pts	1 participants
Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed Year 8- out of 2 pts	0 participants

Adverse Events

Permacol Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Annie Choi

Covidien

Phone: 781-839-1756

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place