Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

Completed

• Conditions: Ventral Hernia
• Interventions: Device: Bard Ventrio Hernia Patch

• Registration Number: NCT00866814
• Lead Sponsor: C. R. Bard

Brief Summary

This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device and surgical procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-23
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2012-04-19
• Results First Submitted QC: 2012-04-19
• Results First Posted: 2012-05-21
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

1. Male or female, age ≥ 18
2. Be able to undergo study procedures
3. Have signed an Informed Consent form (ICF)
4. Be diagnosed with a ventral hernia requiring an open surgery for repair.

Exclusion Criteria

1. Patient is participating in another device or drug study.
2. Patient exhibits clinical symptoms indicating infected hernia site.
3. Patient currently has a clean contaminated or contaminated site.
4. Patient has a life expectancy less than 2 years at the time of enrollment.
5. Anything in the opinion of the Investigator that would preclude the use of the Ventrio Hernia Patch, or preclude the subject from completing the follow-up requirements.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ventrio Group	Bard Ventrio Hernia Patch	Patients diagnosed with a ventral hernia requiring an open surgery for repair.

Primary Outcome Measures

Name	Time	Method
The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.	1 year post surgery	A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.

Secondary Outcome Measures

Name	Time	Method
Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital.	From the time of surgery to hospital discharge, an average of 1-2 days	In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure.	Hospital discharge through 21 days post surgery	In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.	22 days post surgery through 1 year post surgery	In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey	Baseline and post-surgery at week 2, month 6 and month 12	Mean Quality of Life scores at each study visit for the "sensation of mesh," "pain," and "movement limitation" components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure.
Procedure Time	Day of surgery	Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.

Trial Locations

Locations (7)

Sutter Medical Group GNS; 🇺🇸 Sacramento, California, United States

Sacred Heart Health System, Inc.; 🇺🇸 Pensacola, Florida, United States

RUSH Univeristy Medical Center; 🇺🇸 Chicago, Illinois, United States

Associated Surgical Group; 🇺🇸 Peoria, Illinois, United States

Gaston Memorial Hospital; 🇺🇸 Gastonia, North Carolina, United States

Novant Clinical Research Institute; 🇺🇸 Winston-Salem, North Carolina, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States