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

NCT ID: NCT01214252

Last Updated: 2014-05-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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Conditions

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Abdominal Wall Defects

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Permacol Patients

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

Intervention Type DEVICE

Permacol Surgical Implant

Interventions

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Permacol Surgical Implant

Permacol Surgical Implant

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Annie Choi

Bedford, Massachusetts, United States

Site Status

Countries

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United States

References

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Chand B, Indeck M, Needleman B, Finnegan M, Van Sickle KR, Ystgaard B, Gossetti F, Pullan RD, Giordano P, McKinley A. A retrospective study evaluating the use of Permacol surgical implant in incisional and ventral hernia repair. Int J Surg. 2014;12(4):296-303. doi: 10.1016/j.ijsu.2014.01.025. Epub 2014 Feb 5.

Reference Type DERIVED
PMID: 24508570 (View on PubMed)

Other Identifiers

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COVPERH0046

Identifier Type: -

Identifier Source: org_study_id

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