Ventral Hernia
Conditions
Keywords
Infected ventral hernia, Contaminated incisional hernia
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.
Interventions
DEVICEXenMATRIX mesh
Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair
PROCEDUREOpen abdominal ventral hernia repair
Abdominal ventral hernia repair with native tissue
Sponsors
Bard Ltd
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Incidence of Postoperative Hernia Recurrence | two years after surgery date |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the Short-term Clinical Outcomes of Postoperative Wound Events | two years after surgery date | — |
| Length of Hospital Stay | Number of days up to 1 week | Participants will be followed for the duration of the hospital stay, an expected average of 1 week |
| Length of Resource Utilization | two years after surgery date | — |
| Antibiotic Usage and Days | two years after surgery date | — |
| Resumption of Activities of Daily Living | two years after surgery date | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XenMATRIX Use of XenMATRIX mesh to repair hernia
XenMATRIX mesh: Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study stopped prematurely | 9 |
Baseline characteristics
| Characteristic | XenMATRIX |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
The Incidence of Postoperative Hernia Recurrence
Time frame: two years after surgery date
Population: No data collected
Secondary
Antibiotic Usage and Days
Time frame: two years after surgery date
Population: No data collected
Secondary
Compare the Short-term Clinical Outcomes of Postoperative Wound Events
Time frame: two years after surgery date
Population: No data collected
Secondary
Length of Hospital Stay
Participants will be followed for the duration of the hospital stay, an expected average of 1 week
Time frame: Number of days up to 1 week
Population: No data collected
Secondary
Length of Resource Utilization
Time frame: two years after surgery date
Population: No data collected
Secondary
Resumption of Activities of Daily Living
Time frame: two years after surgery date
Population: No data collected