Clinical trial NCT03450473: A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair
Official title: A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Ventral
Keywords: Mesh
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Large abdominal wall hernias are surgically challenging to repair and often associated with significant postoperative complications. Risk factors associated with surgical site complications, such as infection and wound dehiscence, include obesity, diabetes, and smoking. In these high risk patients, the placement of synthetic mesh increases the risk of mesh infection, enterocutaneous fistula formation, and mesh explantation. One of the larger studies of risk factors associated with mesh explantation demonstrated concomitant intra-abdominal procedures have a greater than 6-fold increased hazard of subsequent mesh explantation. As an alternative to synthetic meshes, bioprosthetic meshes derived from the decellularization and processing of allogeneic or xenogeneic tissue sources have been introduced that can often allow the surgeon to treat the surgical site occurrences and salvage the repair without required mesh explantation. Low rates of mesh infection and explantation have been reported for bioprosthetic meshes and are recommended in these complicated patients by the Ventral Hernia Working Group, based on the best available clinical evidence. Despite widespread use of bioprosthetic mesh, there continues to be concern for complications associated with their use (i.e. high seroma and recurrence rates, etc.). This has led to the modification of these matrices by several industry leaders (Acelity, Cook, Integra, etc.) to include a fenestrated platform to allow for fluid to flow through the matrix upon implantation while supporting regeneration in complex abdominal wall reconstruction. To our knowledge, there are no clinical studies prospectively evaluating the long term clinical outcomes for abdominal wall reconstruction procedures involving fenestrated macropourous biologic matrices.This macroporous technology allows for tissue revascularization and integration of the biologic graft and thus an expected improvement in overall outcome. Bioprosthetic fenestrated materials such as Surgimend MP® were developed to assist with earlier incorporation and vascularization of the biologic graft while providing reinforcement of hernia repair. However, there is an absence of high quality prospective data regarding the use of these materials in complicated abdominal wall reconstruction, and no comparative data exists.

This study is a prospective, case series study evaluating the efficacy and performance of SurgiMend MP® during complex ventral hernia repairs. This case series involves a biologically derived hernia mesh under its cleared FDA indication for hernia repair. Efficacy will be determined by quantifying surgical complications, hernia recurrence, and cost effectiveness endpoints.

Detailed description: Large abdominal wall hernias are surgically challenging to repair and often associated with significant postoperative complications. Risk factors associated with surgical site complications, such as infection and wound dehiscence, include obesity, diabetes, and smoking. In these high risk patients, the placement of synthetic mesh increases the risk of mesh infection, enterocutaneous fistula formation, and mesh explantation. One of the larger studies of risk factors associated with mesh explantation demonstrated concomitant intra-abdominal procedures have a greater than 6-fold increased hazard of subsequent mesh explantation. As an alternative to synthetic meshes, bioprosthetic meshes derived from the decellularization and processing of allogeneic or xenogeneic tissue sources have been introduced that can often allow the surgeon to treat the surgical site occurrences and salvage the repair without required mesh explantation. Low rates of mesh infection and explantation have been reported for bioprosthetic meshes and are recommended in these complicated patients by the Ventral Hernia Working Group, based on the best available clinical evidence. Despite widespread use of bioprosthetic mesh, there continues to be concern for complications associated with their use (i.e. high seroma and recurrence rates, etc.). This has led to the modification of these matrices by several industry leaders (Acelity, Cook, Integra, etc.) to include a fenestrated platform to allow for fluid to flow through the matrix upon implantation while supporting regeneration in complex abdominal wall reconstruction. To our knowledge, there are no clinical studies prospectively evaluating the long term clinical outcomes for abdominal wall reconstruction procedures involving fenestrated macropourous biologic matrices.This macroporous technology allows for tissue revascularization and integration of the biologic graft and thus an expected improvement in overall outcome. Bioprosthetic fenestrated materials such as Surgimend MP® were developed to assist with earlier incorporation and vascularization of the biologic graft while providing reinforcement of hernia repair. However, there is an absence of high quality prospective data regarding the use of these materials in complicated abdominal wall reconstruction, and no comparative data exists.

This study is a prospective, case series study evaluating the efficacy and performance of SurgiMend MP® during complex ventral hernia repairs. This case series involves a biologically derived hernia mesh under its cleared FDA indication for hernia repair. Efficacy will be determined by quantifying surgical complications, hernia recurrence, and cost effectiveness endpoints.

Subjects will be identified by the investigators and/or personnel assigned by the investigators, as patients with large complex ventral hernia expected to be repaired with bioprosthetic mesh.

Subjects will have a baseline visit where they will have a physical exam and complete quality of life questionnaires and a pain scale. Photographs will be taken at this visit as well. Demographic and medical and surgical history will be collected. The investigators will then assess the subject intra-operatively to confirm the need and appropriate placement of SurgiMend mesh. The subjects that have mesh placed will be followed at hospital discharge, 3 months, 6 months, and 12 months to assess for changes in health, adverse events, questionnaire completion, and evaluation of surgical site for complications and recurrence. The visits may take place by phone if the subject cannot return to clinic.

Eligibility criteria: Inclusion Criteria:

1. Men or women ≥ 18 years of age and able to give their own consent.
2. The subject is able and willing to comply with study procedures and a signed and dated informed consent is obtained.
3. The subject has a complex ventral hernia
4. The surgeon intends to use bioprosthetic mesh in the repair of the hernia
5. The hernia meets the definition of complex.

   For this study a hernia defect will be considered complex if:

   5.1. a hernia defect is large enough to require component separation to achieve midline fascial closure under physiologic tension 5.2. or the surgical wound is class II -potentially contaminated or class III - contaminated without signs of infection as defined by the CDC wound classification (see Table 1) 5.3. or a patient classified as at risk for surgical site complications by having 2 or more of the following comorbidities:
   * Current smoker or recent history of smoking
   * Obesity (BMI ≥ 30)
   * Type I or Type II diabetes
   * Chronic Obstructive Pulmonary Disease (COPD)
   * Poor nutritional status as judged by the Investigator
   * Current immunosuppressive therapy
   * Current and/or recent (within 30 days of planned surgery) Corticosteriod use
   * Prior Mesh infection
6. Life expectancy of the patient is considered by the physician to be greater than at least 1 year
7. The subject has no known hypersensitivity to bovine collagen
8. The subject has no obvious condition interfering with their ability to comply with the treatment regimen
9. The subject is willing and capable of returning for all follow-up evaluations, in the opinion of the treating physician

Exclusion Criteria:

Pre-Operative Exclusion:

1. \< 18 years of age
2. Have abdominal loss of domain such that the operation would be impractical or would adversely affect respiratory or cardiovascular function to an unacceptable degree in the opinion of the Investigator
3. Participation in an investigational drug or device study within the past 6 weeks prior to enrollment into this trial
4. Have a known collagen metabolism disorder or any medical condition that could interfere with normal tissue healing process as determined by the Investigator

Intra-Operative Exclusion Criteria:

Subjects will be excluded from the study after the index operation if any of the following exclusion criteria are met:

1. Primary closure of the skin and subcutaneous tissue is not achieved at the index operation
2. Bioprosthetic mesh was not used in the repair for any reason
3. Primary Fascial closure unable to be obtained i.e. bridged closure
4. Unable to place the mesh in the retrorectus space (no intraperitoneal placement)

Primary outcomes:
measure: The Frequency of Hernia Recurrence Diagnosed by Physical Exam or CT Scan (if Clinically Indicated)
timeFrame: 36 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Grant Bochicchio, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: