Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Synthetic Mesh 		Synthetic mesh (mid-density polypropylene (generic) Bard soft mesh) will be used in open ventral hernia repair
  • Device: Synthetic Mesh
    Synthetic mesh used during open ventral hernia repair
Active Comparator
Biologic Mesh 		Biologic mesh (non cross linked porcine acellular dermal matrix: Strattice) will be used in open ventral hernia repair
  • Device: Biologic Mesh
    Biologic mesh used during open ventral hernia repair

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.