Large Abdominal Hernia Repair With SurgiMend 3.0

Repair of Large Abdominal Hernia Defects By A Novel Biologic Mesh: A Prospective Multi-Center Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00892333

Acronym

BRIDGE

Enrollment

122

Registered

2009-05-04

Start date

2009-04-30

Completion date

2014-07-31

Last updated

2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia

Keywords

Repair of a large hernia with SurgiMend 3.0, a biologic mesh

Brief summary

The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being that such rate will be less than 20% at one year, representing a 50% reduction over the historic rate of 40%.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

All three of the following criteria must be present for enrollment into the study: * Large abdominal hernia * Inability to close the fascia primarily * Contra-indication for the use of synthetic mesh * Age \> 18 years

Exclusion criteria

* Use of SurgiMend 3.0 to simply reinforce a complete closure of the fascia performed either primarily or sequentially or by component separation technique * Inability to close the skin over the SurgiMend 3.0

Design outcomes

Primary

Measure	Time frame
Hernia recurrence	1 year

Countries

United States

Outcome results