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

Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04534920
• Other study ID #: 14073
• Status: Active, not recruiting
• Start date: July 27, 2020
• Est. completion date: December 13, 2021

Study information

• Verified date: August 2021
• Source: New York Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia

Locations

Country	Name	City	State
United States	Westchester Medical center	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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