NCT04534920

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

August 25, 2020

Last Update Submit

August 31, 2021

Conditions

Hernia

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westchester Medical center

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Rifat Latifi, MD

    Chairman Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Felicien Steichen Professor and Chairman of Surgery

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 1, 2020

Study Start

July 27, 2020

Primary Completion

December 13, 2021

Study Completion

December 13, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

US(1)