Clinical Trials Logo
  1. Home
  2. Ventral Hernia
  3. NCT04853550
  4. Details
NCT04853550 Clinical Trial

Long-Term Follow-up After Ventral Hernia Repair With Strattice Mesh

Ventral Hernia Clinical Trial

Official title:
Long Term Follow-up After Ventral Hernia Repair With Strattice Mesh

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04853550
Other study ID # 19.0980
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 13, 2019
Est. completion date November 14, 2022

Study information
Verified date June 2023
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will assess long-term outcomes (greater than 12 months) following ventral hernia repair with Strattice mesh reinforcement.

Description:

Subjects will be retrospectively identified as having undergone operative repair of ventral hernia with Strattice mesh reinforcement during the period January 1, 2013 - November 1, 2017. Follow-up data will be collected either at a postoperative clinic visit or via telephone interview.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date November 14, 2022
Est. primary completion date November 14, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Hernia repair with Strattice Mesh - Age 18 or older Exclusion Criteria: - Under age 18 - No history of hernia repair

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Strattice Mesh
Subjects will be restrospectively identified has having undergone ventral hernia repair with Strattice mesh reinforcement. Once identified long term follow-up data will be collected.

Locations
Country Name City State
United States University of Louisville Louisville Kentucky

Sponsors (2)
Lead Sponsor Collaborator
University of Louisville AllerGen NCE Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hernia recurrence Percentage of patients with recurrence at long-term (>12 months) follow-up. 24 Months
Secondary Quality of LIfe Questionnaire Percentage of patients with mean quality of life scores at long-term (>12 months) follow-up. 24 Months
See also
  Status Clinical Trial Phase
Recruiting NCT06016426 - Mass Closure vs Layer by Layer Closure N/A
Recruiting NCT05572021 - A Comparison of the Outcomes in Fortiva and Strattice Mesh N/A
Completed NCT02292264 - Risk Factors and Complications of Ventral Hernia Repair
Completed NCT02263599 - Conservative Treatment For Ventral Hernia
Completed NCT02263625 - Regional Differences In Indication for Ventral Hernia Repair
Completed NCT01961687 - A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair. N/A
Completed NCT01325246 - Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair N/A
Completed NCT03283982 - Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM N/A
Not yet recruiting NCT05526209 - Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia
Completed NCT04438369 - Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair. N/A
Recruiting NCT04173884 - Video-based Collaborative Learning to Improve Ventral Hernia Repair N/A
Recruiting NCT02703662 - Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction Phase 2/Phase 3
Completed NCT03938688 - Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation N/A
Active, not recruiting NCT01719718 - The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair N/A
Completed NCT03342040 - Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair N/A
Completed NCT04150796 - Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernias N/A
Recruiting NCT03222102 - Ventral Hernia Prevention After Liver Transplantation N/A
Completed NCT05610267 - Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Terminated NCT01794338 - The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients N/A
Completed NCT01886963 - A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair N/A