Phasix Mesh Use in Complex Open Ventral Hernias Study

Ventral Hernia Clinical Trial

Official title:

Poly-4-hydroxybutyrate Mesh Versus Current Care of Complex Open Ventral Hernias: A Multi-Center Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04580524
• Other study ID #: HSC-MS-20-0655
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

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