Mesh Type in Ventral Hernia Repair

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03091790

Enrollment

Registered

2017-03-27

Start date

2017-03-27

Completion date

2021-07-31

Last updated

2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventral Hernia

Keywords

ventral hernia, mesh

Brief summary

Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.

Interventions

DEVICESynthetic Mesh

Synthetic mesh used during open ventral hernia repair

DEVICEBiologic Mesh

Biologic mesh used during open ventral hernia repair

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient scheduled for open ventral hernia repair at LBJ General Hospital

Exclusion criteria

* Active infection * Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis) * Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown) * Patient unlikely to follow-up (i.e. no phone)

Design outcomes

Primary

Measure	Time frame	Description
Complication free at 1 year post-operative	1 year after surgery	Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation

Secondary

Measure	Time frame	Description
Complication free at 3 years post-operative	3 years after surgery	Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
Dindo-clavien complications	Pre-operative, 1 month after surgery, 1 year and 3 years after surgery	Grade I to V
Patient centered outcomes	Pre-operative, 1 month after surgery, 1 year and 3 years after surgery	includes patient satisfaction, cosmetic satisfaction, modified assessment scale
Cost	1 year and 3 years after surgery	charges for all patient visits, admissions, and procedures

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026