A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair
Phase: NA
Conditions: Hernia, Ventral
Sponsor: Washington University School of Medicine

 
A PROSPECTIVE CASE SERIES EVALUATING SURGIMEND MP® IN PATIENTS UNDERGOING 
COMPLEX ABDOMINAL HERNIA REPAIR  
February 20, 2020 
 
Study Design 
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.    
 
Study Objectives: 
 
Primary Objective  
The objective of this study is to evaluate the effectiveness and performance of SurgiMend MP® 
abdominal wall reinforcement in patients with complex ventral hernia repair as assessed by the 
frequency of hernia recurrence and/or bulging, defined as a contour deformity with or without 
a fascial defect based on physical examination or computed tomography. 
Secondary Objectives 
• 
To assess the frequency of intra-operative mesh-related complications 
• 
To assess short term surgical complication rates in complex hernia repairs 
• 
To assess the comparative cost effectiveness and quality of life (QOL) of interventions in 
complex hernia repairs 
 
Treatments/Methods 
The study will follow consenting adults with a large, complex abdominal wall hernia.  The 
specific definition of this population is described in the Inclusion/Exclusion criteria.  These 
consenting adults with complex abdominal wall hernias will undergo a hernia repair procedure.  
The treatment includes hernia repair reinforcement with SurgiMend MP® repair mesh.  
 
Study Duration 
A subject will participate in the study for approximately 3 years in total.  Following enrollment 
into the study and the index operation, the patient will be followed until hospital discharge, 
with subsequent follow-up visits at approximately 3 months, 6 months, 1 year, 2 years, and 3 
years.