NCT01961687

A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.

Detailed description

The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ Mesh in subjects requiring primary ventral, incisional or first-recurrent (protocol version 1.4)/multiply-recurrent (protocol version 2.0) hernia repair in subjects at high risk for complications. Subjects at high risk are defined as having 1 or more of the following co-morbidity conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.

Conditions

• Ventral Hernia
• Incisional Hernia

Interventions

Type	Name	Description
DEVICE	Resorbable Mesh	Phasix Mesh

Timeline

• Start date: 2013-09-01
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2013-10-11
• Last updated: 2021-01-26
• Results posted: 2021-01-26

Locations

16 sites across 1 country: United States