Clinical trial NCT01295125: Comparative Study of Biologic Mesh Versus Repair With Component Separation.
Official title: Randomized Control Trial of Biologic Mesh (XenMATRIXTM) vs. Component Separation Alone in Contaminated Ventral Hernia Repair:a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventral Hernia
Keywords: Infected ventral hernia
Contaminated incisional hernia
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Bard Ltd
First posted: 2011-02-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Incidence of Postoperative Hernia Recurrence
timeFrame: two years after surgery date
Secondary outcomes:
measure: Compare the Short-term Clinical Outcomes of Postoperative Wound Events
timeFrame: two years after surgery date
measure: Length of Hospital Stay
timeFrame: Number of days up to 1 week
measure: Length of Resource Utilization
timeFrame: two years after surgery date
measure: Antibiotic Usage and Days
timeFrame: two years after surgery date
measure: Resumption of Activities of Daily Living
timeFrame: two years after surgery date
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Michael J. Rosen, MD.
role: PRINCIPAL_INVESTIGATOR
References: