Mesh Type in Ventral Hernia Repair

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03091790
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventral Hernia	Device: Synthetic Mesh; Device: Biologic Mesh	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mesh Type in Ventral Hernia Repair
• Actual Study Start Date: Mar 27, 2017
• Anticipated Primary Completion Date: Mar 31, 2020
• Anticipated Study Completion Date: Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Complication free at 3 years post-operative [3 years after surgery]

   Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation

2. Dindo-clavien complications [Pre-operative, 1 month after surgery, 1 year and 3 years after surgery]

   Grade I to V

3. Patient centered outcomes [Pre-operative, 1 month after surgery, 1 year and 3 years after surgery]

   includes patient satisfaction, cosmetic satisfaction, modified assessment scale

4. Cost [1 year and 3 years after surgery]

   charges for all patient visits, admissions, and procedures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Health at Lyndon B. Johnson General Hospital	Houston	Texas	United States	77026

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Mike Liang, M.D., UT Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mike K Liang, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03091790
• Other Study ID Numbers: HSC-MS-16-0936
• First Posted: Mar 27, 2017
• Last Update Posted: Apr 13, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mike K Liang, Assistant Professor, The University of Texas Health Science Center, Houston: ventral hernia; mesh
• Additional relevant MeSH terms: Hernia; Hernia, Ventral

Study Results

No Results Posted as of Apr 13, 2020