NCT06409091

Brief Summary

This study compares short term outcomes of patients undergoing a hernia repair with heavy weight mesh vs medium weight mesh in clean-contaminated and contaminated cases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,496

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

11.5 years

First QC Date

May 7, 2024

Last Update Submit

May 12, 2024

Conditions

Hernia, VentralHernia Incisional

Outcome Measures

Primary Outcomes (1)

  • Wound complications

    Wound complcations

    30 days post op

Secondary Outcomes (3)

  • Mesh removal

    30 days post op

  • Readmissions

    30 days post op

  • Reoperations

    30 days post op

Study Arms (2)

Medium weight PP mesh

Patients receiving medium weight PP mesh in clean-contaminated and contaminated settings

Device: Medium weight or Heavy weight mesh

Heavy Weight PP Mesh

Patients receiving heavy weight PP mesh in clean-contaminated and contaminated settings

Device: Medium weight or Heavy weight mesh

Interventions

Medium weight or Heavy weight meshDEVICE

Patients received a hernia repair with one of the two groups

Heavy Weight PP MeshMedium weight PP mesh

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent open ventral hernia repairs with synthetic mesh in contaminated and clean-contaminated hernia repair surgeries.

You may qualify if:

  • Patients undergoing open ventral hernia repairs with synthetic mesh in contaminated and clean contaminated surgery

You may not qualify if:

  • Laparoscopic or robotic surgery
  • clean cases or dirty cases
  • pregnancy
  • under age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hernia, VentralIncisional Hernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 10, 2024

Study Start

January 1, 2012

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

This data will not be shared with other researchers other than through peer-reviewed publication

Locations

US(1)