Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04580524
Other study ID # HSC-MS-20-0655
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2021
Est. completion date April 2021

Study information

Verified date June 2023
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (18 years or older) with a complex ventral hernia scheduled for repair Exclusion Criteria: - Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement) - Unlikely to follow-up (live out of state, unable to be reached by phone or email) - Non-English and non-Spanish speakers - Pregnant or breast-feeding patients - Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Repair of ventral hernia using biologic mesh
Ventral hernia will be repaired using biologic mesh
Repair of ventral hernia using suture repair or synthetic mesh
Ventral hernia will be repaired using the current treatment methods

Locations

Country Name City State
United States Lyndon B. Johnson General Hospital Houston Texas
United States Memorial Hermann Hospital-Texas Medical Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major complication free A composite of hernia recurrence, reoperation, chronic wound complication, or death 2 years post-operative
Secondary Surgical site occurrences Surgical site infection, seroma, hematoma, and skin dehiscence 90 days post-operative
Secondary Clavien-Dindo complication grade Clavien-Dindo complication grade 90 days post-operative
Secondary Hospital duration Days in hospital composed of post-operative length of stay and readmissions 90 days post-operative
Secondary Emergency room visits Number of times ER was visited 90 days post-operative
Secondary Cost Analysis Analysis of costs as performed from the healthcare perspective 2 years
Secondary Post-operative abdominal pain Measured by the visual analogue scale (VAS) Day of consent and post-operatively at 1 month, 1 year and 2 years
Secondary Patient centered outcomes Abdominal wall health status (AW-HS) measured through the modified activities assessment scale (mAAS) Day of consent and post-operatively at 1 month, 1 year and 2 years
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 NCT02263625 - Regional Differences In Indication for Ventral Hernia Repair
Completed NCT02263599 - Conservative Treatment For Ventral Hernia
Completed NCT02292264 - Risk Factors and Complications of 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
Completed 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