Comparative Study of Biologic Mesh Versus Repair With Component Separation.

Ventral Hernia Clinical Trial

— Davol  

Official title:

Randomized Control Trial of Biologic Mesh (XenMATRIXTM) vs. Component Separation Alone in Contaminated Ventral Hernia Repair:a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01295125
• Other study ID #: 11-10-23
• Status: Terminated
• Phase: N/A
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare open abdominal incisional hernia repair using XenMATRIX biologic mesh versus repair with their own tissue. This study will provide information in determining if a biological mesh is necessary to provide a sturdy repair for a ventral hernia.

Description:

This study will involve comparison of open abdominal incisional hernia repair with XenMATRIX biologic graft versus repair with native tissue. The current study seeks to evaluate XenMATRIXTM, an FDA approved biologic graft for repairing contaminated abdominal wall defects. This study will provide significant insight for the reconstructive surgeon and patient to determine whether a biologic graft is necessary for the reconstruction of a contaminated ventral hernia repair to provide a durable single staged repair.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Is an adult = 18 years old of either gender

2. Will undergo a planned open abdominal incisional hernia repair

3. Has a defect that can be repaired primarily without tension with myofascial advancement flaps and requires no more than 1 piece of surgical mesh (largest mesh size (19 x 35 cm)

4. Contamination is known preoperatively, e.g. repair in the presence of a chronic wound, the presence of a stoma or in conjunction with a bowel resection, or such contaminations occurs intraoperatively, e.g. inadvertent enterotomy or opening of other hollow intra-abdominal viscus

5. Infection is known due to local frank signs of incisional drainage, fistula formation or abdominal abscess following prior surgical abdominal surgery or presence of infected mesh

6. Has an estimated hernia size of = 3cm to 20cm in maximal width by physical exam

7. Is considered a clean-contaminated or contaminated case per Surgical Site Infection Risk Guidelines

8. Is willing and able to return for all scheduled and required study visits

9. Is willing and able to provide written informed consent for study participation

Exclusion Criteria:

1. Has a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh

2. Is a clean or dirty case per Surgical Site Infection Risk Guidelines

3. Has conditions that would adversely affect subject safety as per product labeling

4. Will undergo a laparoscopic hernia repair

5. Has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh

6. Has conditions which preclude abdominal imaging at a standard imaging facility

7. Has an anticipated survival of < 24 months

8. Care plan is to perform a staged repair over 45 days

9. Is bedridden or otherwise non-ambulatory (i.e. is unable to independently transfer into and out of a wheelchair)

10. Is ASA class 4 or 5

11. BMI over 45

12. Is pregnant

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• XenMATRIX mesh
Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair

Procedure:
• Open abdominal ventral hernia repair
Abdominal ventral hernia repair with native tissue

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Bard Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incidence of Postoperative Hernia Recurrence		two years after surgery date
Secondary	Compare the Short-term Clinical Outcomes of Postoperative Wound Events		two years after surgery date
Secondary	Length of Hospital Stay	Participants will be followed for the duration of the hospital stay, an expected average of 1 week	Number of days up to 1 week
Secondary	Length of Resource Utilization		two years after surgery date
Secondary	Antibiotic Usage and Days		two years after surgery date
Secondary	Resumption of Activities of Daily Living		two years after surgery date