Short Term Outcomes of Heavy-weight Versus Medium-weight... | NCT06409091

Studies
Short Term Outcomes of Heavy-weight Versus Medium-weight Synthetic Mesh

NCT06409091

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

May 14, 2024Actual

Enrollment

1,496Actual

Phase

Not provided

Conditions

Hernia, Ventral
Hernia Incisional

Interventions

Medium weight or Heavy weight mesh

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Jun 30, 2023Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

May 7, 2024

First Submission Date that Met QC Criteria

May 7, 2024

First Posted Date

May 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2024

Last Update Posted Date

May 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The Abdominal Core Health Quality Collaborative was queried for patients undergoing open retromuscular hernia repairs with both heavy weight polypropylene (PP) mesh and medium weight PP mesh in cases where there was clean-contaminated and contaminated surgeries. The short term outcomes were then evaluated including wound infections, readmissions, recurrences of the hernia, and quality of life scores.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,496Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Medium weight or Heavy weight mesh	Device	Patients received a hernia repair with one of the two groups	Heavy Weight PP Mesh Medium weight PP mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound complications	Wound complcations	30 days post op

Secondary Outcomes

Measure	Description	Time Frame
Mesh removal	mesh removal after surgery	30 days post op
Readmissions	readmission or ER visit after surgery	30 days post op

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic		Cleveland	Ohio	44195	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006555	Hernia, Ventral
D000069290	Incisional Hernia

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided