N/A N=24 Other

A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair

Hernia, Ventral

Bottom Line

View on ClinicalTrials.gov: NCT03450473 ↗

Enrolled (actual)

Serious AEs

15.0%

Results posted

Feb 2023

Primary outcome: Primary: The Frequency of Hernia Recurrence Diagnosed by Physical Exam or CT Scan (if Clinically Indicated) — 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SurgiMend® MP (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY The Frequency of Hernia Recurrence Diagnosed by Physical Exam or CT Scan (if Clinically Indicated)	1	—

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.

Eligibility Criteria

Inclusion Criteria

Men or women ≥ 18 years of age and able to give their own consent.
The subject is able and willing to comply with study procedures and a signed and dated informed consent is obtained.
The subject has a complex ventral hernia
The surgeon intends to use bioprosthetic mesh in the repair of the hernia
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
Life expectancy of the patient is considered by the physician to be greater than at least 1 year
The subject has no known hypersensitivity to bovine collagen
The subject has no obvious condition interfering with their ability to comply with the treatment regimen
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:

< 18 years of age
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
Participation in an investigational drug or device study within the past 6 weeks prior to enrollment into this trial
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:

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03450473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.