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

NCT03450473 | Completed Results FDA Device

• 1 other identifier: WU001 Surgimend Mp®
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Ventral

Keywords

Mesh

Outcome Measures

Primary Outcomes (1)

• The Frequency of Hernia Recurrence Diagnosed by Physical Exam or CT Scan (if Clinically Indicated)

  The frequency of hernia recurrence diagnosed by physical exam or CT Scan (if clinically indicated)

  36 Months

Study Arms (1)

SurgiMend® MP

OTHER

Patients will not be randomized as this is a case series study involving the evaluation of only 1 type of mesh (SurgiMend MP®).

Device: SurgiMend® MP

Interventions

SurgiMend® MP DEVICE

SurgiMend MP® is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs. SurgiMend MP® will be used for abdominal wall reinforcement in patients with complex ventral hernia repair.

SurgiMend® MP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• \< 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
• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Grant Bochicchio
• Organization: Washington University School of Medicine in St. Louis

gbochicchio@wustl.edu

314-362-9347

Study Officials

• Grant Bochicchio, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: March 1, 2018
• Study Start: January 3, 2018
• Primary Completion: March 11, 2022
• Study Completion: December 31, 2022
• Last Updated: February 15, 2023
• Results First Posted: February 15, 2023

Record last verified: 2023-01

Locations

US (1)