Comparison of Sample Characteristics Between Subjects Who Received Strattice Mesh for Abdominal Wall Reconstruction

Comparison of Sample Characteristics Between the Subjects Who Received Strattice Mesh for Abdominal Wall Reconstruction at Westchester Medical Center vs Americas Hernia Society Quality Collaborative (AHSQC) Registry Dataset

Two different datasets from Institutional Review Board (IRB) approved studies L#12,083 and L#12,086 will be used to compare the sample characteristics between subjects who received Strattice mesh for abdominal wall reconstruction at Westchester Medical Center and Americas Hernia Society Quality Collaborative (AHSQC) registry.

Study Overview

• Status: Active, not recruiting
• Conditions: Hernia

Detailed Description

Abdominal wall defects or hernias are commonly seen after open surgery performed electively or under emergent conditions. During the last decade numerous advances have been made in the management of patients with abdominal wall defects. These defects are repaired by various surgical techniques including mesh repair (synthetic vs. biologic), primary repair, etc. However, the outcomes of patients after these injuries are highly variable and many of these patients suffer from in-hospital complications, mesh infections requiring explantation, and recurrence. Various factors play a role in the final outcome of the patient. These include factors associated with the reasons for initial surgery or disease (trauma or emergency general surgery), patient demographics (age, gender, co-morbidities), preoperative features (hemoglobin and other biochemical indicators, surgical technique used during the repair and use of repair (onlay, inlay, retro rectus) and the types of mesh used.

Study Design Two different datasets from Institutional Review Board (IRB) approved studies L#12,083 and L#12,086 will be used to compare the sample characteristics between subjects who received Strattice mesh for abdominal wall reconstruction at Westchester Medical Center and Americas Hernia Society Quality Collaborative (AHSQC) registry.

Primary Objective: To determine the degree to which our sample of Strattice® recipients resemble AHSQC Strattice® recipients.

Study Summary:

This study involves two different datasets from our existing studies L#12083 and L#12,086 which are approved by New York Medical College, IRB on 6/14/2017and 7/7/2017 respectively.

Study L#12,083 is a retrospective data collection of subjects who had abdominal wall reconstruction and received Strattice mesh during 1/1/2011 to 12/31/2018 at Westchester Medical Center. A total of 105 records from this study will be used for comparison study. Study L#12086 is a prospective study of subjects who had abdominal wall reconstruction using biological mesh. A total of 77 records will be used from this study. From both the studies combined we have about a total of 182 records of extracted data and same data variables will be used to compare with AHSQC registry. The data that will be compared includes preoperative info, hospital course, complications, re-hospitalizations and 2weeks follow-up.

Research Subject Population:

Number of Subjects Total of 182 records met the inclusion criteria and data has been collected.

Gender of Subjects There will be no gender based restrictions for this study.

Age of Subjects Subjects 18 to 85 years old will be included in this study.

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• United States
  • New York
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All male and female subjects who were between 18 to 85 years old, who had complex abdominal wall reconstruction at Westchester Medical Center and received biologic mesh during 1/1/2011 to 12/31/2018 are included in this study.

Description

Inclusion Criteria:

• Subjects 18 to 85 years old
• Subjects who had complex abdominal wall reconstruction and received biologic mesh are included in the study

Exclusion Criteria:

• Subjects below 18 years of age and above the age of 85 years are excluded.
• Any hernia repair not using biologic mesh are excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of sample characteristics between WMC Strattice® recipients and AHSQC Strattice® recipients	Comorbidities, operative details, mesh size and location, number of drains, surgical site infection and readmissions.	from 1/1/2011 to 12/31/2018

Collaborators and Investigators

• Sponsor: New York Medical College

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Anticipated): December 13, 2021
• Study Completion (Anticipated): December 13, 2021

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 14073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No