Hernia, Ventral, Intestinal Fistula, Fibromatosis, Abdominal
Conditions
Keywords
Hernia, Abdominal wall reconstruction, Abdominal wall defect, Porcine mesh, Component separation, Abdominal wall tumor, Desmoid
Brief summary
The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.
Detailed description
This is a prospective, randomized-controlled trial comparing two porcine acellular matrices in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of mesh used while surgeons are not). Our goals in this study are: 1. PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively 2. SECONDARY OUTCOMES i. To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days and 1 year postoperatively 1. Infection 2. Seroma 3. Hematoma 4. Wound dehiscence 5. Skin necrosis 6. Formation of enterocutaneous fistula 7. Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient pain, physical functioning and quality of life after hernia repair between XenMatrix and Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C. Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey
Interventions
PROCEDUREAbdominal wall reconstruction with Strattice
Abdominal wall reconstruction using Strattice
OTHERAssess pain intensity at last office visit preoperatively
Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
OTHERAssess pain interference at last office visit preoperatively
Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
OTHERAssess physical functioning at last office visit preoperatively
Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
OTHERAssess patient quality of life at last office visit preoperatively
Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
OTHERAssess patient pain intensity postoperatively
Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
OTHERAssess pain interference postoperatively
Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
OTHERAssess physical functioning postoperatively
Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
OTHERAssess quality of life postoperatively
Assess quality of life at 1 year postoperatively using the HerQLes survey
OTHERAssess hernia recurrence at 30 days postoperatively
Assess hernia recurrence at 30 days
OTHERAssess bulge at 30 days postoperatively
Assess bulge at 30 days
OTHERAssess Surgical Site Occurrences at 30 days postoperatively
Assess Surgical Site Occurrences at 30 days
OTHERAssess hernia recurrence at 1 year postoperatively
Assess hernia recurrence at 1 year postoperatively
OTHERAssess bulge at 1 year postoperatively
Assess bulge at 1 year postoperatively
OTHERAssess Surgical Site Occurrences at 1 year postoperatively
Assess Surgical Site Occurrences at 1 year postoperatively
OTHERAssess overall complications at 30 days postoperatively
OTHERAssess overall complications at 1 year postoperatively
PROCEDUREAbdominal wall reconstruction with XenMatrix
Abdominal wall reconstruction with XenMatrix
DEVICEStrattice
Strattice mesh
DEVICEXenMatrix
Xenmatrix mesh
Sponsors
Jeffrey Janis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Abdominal wall reconstruction using Strattice
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 * Patients presenting for elective hernia repair, with Ventral Hernia Working Group (VHWG) grade 2 or above (Patients with a hernia who need hernia repair due to hernia size, discomfort, risk of bowel incarceration, effect on physical function), and who have comorbidities or contamination making the use of synthetic mesh contraindicated) * Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease (patients who can have a major surgical procedure without an exceedingly high risk of medical complications such as pulmonary edema, myocardial infarction, pulmonary embolism, renal failure, life-threatening bleeding, stroke). * Patients presenting for resection of large abdominal wall tumors who are expected to undergo have tumor extirpative defect that would require biologic mesh for closure (patients with a large tumor of the abdominal wall who will have a large defect in their fascia after resection, who need biologic mesh for reinforcement).
Exclusion criteria
* Known allergy to porcine products * Active smokers (within the past 4 weeks) presenting for elective hernia repair * Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective hernia repair * Patients presenting for emergent hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively * Patients with severe systemic sepsis * Patients with frank purulence in the wound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Surgical Site Occurrences (SSOs) at 6 Week | 6 week postoperatively | Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include: 1. Infection 2. Seroma 3. Hematoma 4. Wound dehiscence 5. Skin necrosis 6. Formation of enterocutaneous fistula 7. Mesh infection |
Countries
United States
Participant flow
Pre-assignment details
There were no significant events in the study. Enrollment was stopped prior to the pre-determined 70 total participants, as a shift in practice and national trend toward the use of synthetic mesh over biologic mesh hindered participant recruitment.
Participants by arm
| Arm | Count |
|---|---|
| Strattice Assess Bulge Assess Surgical Site Occurrences at 6 weeks Assess Recurrence Assess Seroma Assess Hematoma Assess Infection Assess Dehiscence Assess Skin necrosis | 16 |
| XenMatrix Assess Bulge Assess Surgical Site Occurrences at 6 weeks Assess Recurrence Assess Seroma Assess Hematoma Assess Infection Assess Dehiscence Assess Skin necrosis | 30 |
| Total | 46 |
Baseline characteristics
| Characteristic | Strattice | Total | XenMatrix |
|---|---|---|---|
| Age, Continuous | 60 years | 60 years | 57 years |
| ASA Class Stage I | 0 Participants | 0 Participants | 0 Participants |
| ASA Class Stage II | 3 Participants | 6 Participants | 3 Participants |
| ASA Class Stage IIII | 13 Participants | 37 Participants | 24 Participants |
| ASA Class Stage IV | 0 Participants | 3 Participants | 3 Participants |
| ASA Class Stage V | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index | 29.6 kg/m^2 | 33.1 kg/m^2 | 33.1 kg/m^2 |
| Bridged Repair | 2 Participants | 8 Participants | 6 Participants |
| COPD | 5 Participants | 10 Participants | 5 Participants |
| Diabetes | 7 Participants | 14 Participants | 7 Participants |
| Hernia Width | 15.8 cm | 12.9 cm | 12.9 cm |
| Hypertension | 7 Participants | 21 Participants | 14 Participants |
| Immunosuppression | 2 Participants | 12 Participants | 10 Participants |
| Kanters Grade 1 | 1 Participants | 2 Participants | 1 Participants |
| Kanters Grade 2 | 6 Participants | 22 Participants | 16 Participants |
| Kanters Grade 3 | 9 Participants | 22 Participants | 13 Participants |
| Number of prior Hernia Repairs | 2.5 prior repairs | 1 prior repairs | 1 prior repairs |
| Previous Hernia Repair | 11 Participants | 31 Participants | 20 Participants |
| Primary Fascial Repair | 14 Participants | 36 Participants | 22 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 10 Participants | 24 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 22 Participants | 16 Participants |
| Total OR Time | 471 minutes | 417 minutes | 417 minutes |
| Unilateral Component Separation | 2 Participants | 4 Participants | 2 Participants |
| Ventral Hernia Working Group 1 | 1 Participants | 2 Participants | 1 Participants |
| Ventral Hernia Working Group 2 | 2 Participants | 11 Participants | 9 Participants |
| Ventral Hernia Working Group 3 | 11 Participants | 24 Participants | 13 Participants |
| Ventral Hernia Working Group 4 | 2 Participants | 9 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 30 |
| other Total, other adverse events | 0 / 16 | 0 / 30 |
| serious Total, serious adverse events | 0 / 16 | 0 / 30 |
Outcome results
Primary
Rate of Surgical Site Occurrences (SSOs) at 6 Week
Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include: 1. Infection 2. Seroma 3. Hematoma 4. Wound dehiscence 5. Skin necrosis 6. Formation of enterocutaneous fistula 7. Mesh infection
Time frame: 6 week postoperatively
Population: participants who got to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strattice | Rate of Surgical Site Occurrences (SSOs) at 6 Week | 1 event | Standard Error 6.25 |
| XenMatrix | Rate of Surgical Site Occurrences (SSOs) at 6 Week | 11 event | Standard Error 36.67 |