Hernia, Ventral
Conditions
Keywords
Hernia, Ventral, Incisional, Abdominal, Herniorrhaphy, Recurrence, Infection, Mesh, Biologic, Synthetic
Brief summary
Hernias are often treated using a prosthetic mesh to add support to the healing wound. Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data regarding which type of mesh to use is limited. The purpose of this study is to compare the effects, good and/or bad, of two types of prosthetic meshes: one that is made from pig skin (called a biologic prosthetic), and one that is made in a laboratory (called a synthetic prosthetic). This study will include some patients who have an infection in/near the hernia, and other patients who do not have an infection. We expect the synthetic mesh to be associated with a higher rate of early post-operative surgical site infection and fluid collections (seromas), while we expect the biologic mesh to be associated with a higher rate of recurrence.
Detailed description
This is a prospective, single-blind, randomized study comparing the clinical efficacy and overall costs of two prosthetic meshes in the repair of complex ventral hernias. The two prosthetic meshes to be studied are Ventralight (Bard, Murray Hill, NJ), a synthetic mesh chiefly made of polypropylene and Strattice (LifeCell, Branchburg, NJ), a biologic mesh derived from porcine dermis. The study population will consist of patients who are in need of a repair of a complex ventral hernia. Patients will be enrolled in the study for 24 months following their operation or until they experience a recurrence of their hernia, whichever occurs first. The primary outcome variable is recurrence and the secondary outcome variables are post-operative surgical site infections and overall costs. There is no universally agreed upon definition of what constitutes a complex ventral hernia. For our purposes, a complex ventral hernia is one that involves a compromised surgical field, in which gastrointestinal, biliary, or genitourinary procedures are performed, one in which the wound class is considered clean-contaminated, contaminated, or dirty due to other causes, such as infected meshes and enterocutaneous fistulas, or surgical procedures conducted in patients with large ventral hernia defects (\>10 cm in any single dimension).
Interventions
DEVICEVentralight
DEVICEStrattice
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hobart Harris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical evidence of a midline, ventral hernia, regardless of degree of wound contamination, with the exception of class IV wounds due to the presence/discovery of fecal peritonitis. Specifically, the repair will or will not involve a compromised surgical field in which gastrointestinal, biliary and/or genitourinary procedures will be performed. The surgical wound class may be classified as clean, or it may be classified as clean-contaminated, contaminated, or dirty-infected, due to the repair of an enterocutaneous fistula, takedown of an intestinal stoma and/or removal of infected mesh * Age \>21 * Negative pregnancy test * No allergic, religious or ethical objections to either polypropylene or porcine prosthetics * Signed, witnessed informed consent to take part in the study
Exclusion criteria
* Lactating women * Patients who are unable to commit to the follow evaluations over 24 months * Severe malnutrition (serum albumin \<2.0 in the setting of a normal CRP) * Use of an investigational agent within 1 month prior to study enrollment and/or planned during this study * Presence of pre-existing parenchymal liver disease characterized by the presence of Child's Class C liver dysfunction (including all of the following: bilirubin ≥ 3.0 mg/dL; albumin ≤ 3.0 mg/dL; refractory ascites; encephalopathy or coma; and poor nutritional status) * Immunocompromised patients, as evidenced by: administration of high doses of corticosteroids (i.e. doses ≥ 1.5 mg/kg/day of prednisone or equivalent) within 72 hours before study enrollment; status post solid organ transplant or bone marrow transplant and experiencing acute organ rejection or bone marrow failure or rejection; evidence of neutropenia (absolute neutrophil count ≤ 500 cells/mm3 (≤ 500 x 106 cells/L); chemotherapy or radiation therapy within 90 days before study enrollment; known AIDS; any disease sufficiently advanced to suppress resistance to infection (including, but not limited to leukemia, lymphoma or hypogammaglobulinemia); administration of immunoglobulin of G-CSF within 90 days before study enrollment * Ascites refractory to medical management * Presence of an underlying disease/injury with life expectancy less than two years and/or severe underlying disease that would preclude study entry (e.g. known malignancy) * Wound Classification IV due to the presence/discovery of fecal peritonitis. Other cases of wound class IV including presence of purulent inflammation, soft tissue/mesh infection, or visceral perforation resulting in a contained fistula (e.g. enterocutaneous fistula) are still considered eligible for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair. | up to 24 months after surgery | Number of patients who had a recurrence of hernia, at anytime, up to two years following repair as determined by physical examination, ultrasound or CT scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Experienced Surgical Site Infections. | 30 days after surgery | Number of patients who experienced surgical site infections as determined by physical examination. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Other Surgical Complications | 30 days after surgery | Number of other surgical complications including: urinary tract infections, pneumonia, and Deep Vein Thrombosis/pulmonary embolism. |
| Generic Measure of Health-related Quality of Life and Hernia-specific Measure of Quality of Life With a Focus on Abdominal Wall Function | 24 months after surgery | Quality of life will be measured using the SF-36 and the HerQLes surveys. |
| Overall Cost | 24 months after surgery | Overall costs will be measured using a combination approach comparing actual costs, allowed vs. paid amounts, and Medicare payment rates using diagnosis related groups (DRG) and resource-based relative value scale (RBRVS) data. |
| Activity Level | 24 months after surgery | Activity level will be measured using the Activity Assessment Scale. |
| Number of Surgical Site Occurrences | Up to two years from surgery | Number of surgical site occurrences by type. |
Countries
United States
Participant flow
Recruitment details
Adults (≥21 years of age) with a ventral hernia scheduled for an elective repair were eligible for inclusion. Recruitment and all surgical procedures were carried out from March 2014 through October 2018 at UCSF Medical Center). All participants were recruited via referral to the medical center's surgery clinics. Patients were only enrolled once.
Participants by arm
| Arm | Count |
|---|---|
| Synthetic Patients in this arm will have their ventral hernia repaired utilizing a synthetic prosthetic mesh made of polypropylene.
SoftMesh/Ventralight ST | 83 |
| Biologic Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.
Strattice | 82 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 3 |
| Overall Study | Lost to Follow-up | 2 | 6 |
| Overall Study | study terminated | 16 | 11 |
Baseline characteristics
| Characteristic | Synthetic | Total | Biologic |
|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 11.1 | 55.1 years STANDARD_DEVIATION 12.4 | 55.0 years STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 35 Participants | 21 Participants |
| Race (NIH/OMB) White | 59 Participants | 109 Participants | 50 Participants |
| Region of Enrollment United States | 83 participants | 165 participants | 82 participants |
| Sex: Female, Male Female | 50 Participants | 97 Participants | 47 Participants |
| Sex: Female, Male Male | 33 Participants | 68 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 2 / 83 |
| other Total, other adverse events | 27 / 82 | 19 / 83 |
| serious Total, serious adverse events | 15 / 82 | 20 / 83 |
Outcome results
Primary
Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair.
Number of patients who had a recurrence of hernia, at anytime, up to two years following repair as determined by physical examination, ultrasound or CT scan.
Time frame: up to 24 months after surgery
Population: This measure includes patients that recurred before 2 years and were not followed for 2 years, and some patients that recurred were followed for 2 years.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biologic | Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair. | 25 Participants |
| Synthetic | Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair. | 14 Participants |
Secondary
Number of Patients Who Experienced Surgical Site Infections.
Number of patients who experienced surgical site infections as determined by physical examination.
Time frame: 30 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biologic | Number of Patients Who Experienced Surgical Site Infections. | 32 Participants |
| Synthetic | Number of Patients Who Experienced Surgical Site Infections. | 28 Participants |
Other Pre-specified
Activity Level
Activity level will be measured using the Activity Assessment Scale.
Time frame: 24 months after surgery
Other Pre-specified
Generic Measure of Health-related Quality of Life and Hernia-specific Measure of Quality of Life With a Focus on Abdominal Wall Function
Quality of life will be measured using the SF-36 and the HerQLes surveys.
Time frame: 24 months after surgery
Other Pre-specified
Number of Other Surgical Complications
Number of other surgical complications including: urinary tract infections, pneumonia, and Deep Vein Thrombosis/pulmonary embolism.
Time frame: 30 days after surgery
Population: Only patients with other surgical complications were included in this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biologic | Number of Other Surgical Complications | Urinary tract infection | 13 occurence |
| Biologic | Number of Other Surgical Complications | Pneumonia | 4 occurence |
| Biologic | Number of Other Surgical Complications | Deep Vein Thrombosis/pulmonary embolism | 7 occurence |
| Synthetic | Number of Other Surgical Complications | Urinary tract infection | 7 occurence |
| Synthetic | Number of Other Surgical Complications | Pneumonia | 1 occurence |
| Synthetic | Number of Other Surgical Complications | Deep Vein Thrombosis/pulmonary embolism | 5 occurence |
Other Pre-specified
Number of Surgical Site Occurrences
Number of surgical site occurrences by type.
Time frame: Up to two years from surgery
Population: Only patients with a surgical site occurrence were included in this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biologic | Number of Surgical Site Occurrences | Hematoma | 5 surgical site occurence |
| Biologic | Number of Surgical Site Occurrences | Wound necrosis and other | 9 surgical site occurence |
| Biologic | Number of Surgical Site Occurrences | Seroma | 7 surgical site occurence |
| Synthetic | Number of Surgical Site Occurrences | Seroma | 12 surgical site occurence |
| Synthetic | Number of Surgical Site Occurrences | Wound necrosis and other | 10 surgical site occurence |
Other Pre-specified
Overall Cost
Overall costs will be measured using a combination approach comparing actual costs, allowed vs. paid amounts, and Medicare payment rates using diagnosis related groups (DRG) and resource-based relative value scale (RBRVS) data.
Time frame: 24 months after surgery