NCT04033055

Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia.

Interventional Study of Antalgic Efficacy of the CycloMesh™ Implant Soaked in Ropivacaine Hydrochloride 10 Mg/mL in the Treatment of Uncomplicated Inguinal Hernia. Randomized Comparative Study Versus CycloMesh™ Soaked in Physiological Saline Solution NaCl 9°/°°

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Quanta Medical · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CycloMesh is a polyester visceral implant functionalized by drug delivery systems directly on its surface, targeting a unique intervention, a slow anesthetic release and an in situ activity. Based on the fact that cyclodextrins are capable of forming inclusion complexes with amino-amide anaesthetic agents, ropivacaine and cyclodextrins were combined on a commercial visceral mesh.This enables CycloMesh to release ropivacaine for a sustained period in order to improve patient's comfort after inguinal hernia surgery. The underlying hypothesis of this work is that clinical gain is achieved by adding a drug delivery system to visceral mesh for the local and prolonged delivery of ropivacaine. This should results in an improvement in quality of life, a reduction in pain and a faster returning to work following treatment of inguinal hernia by lichtenstein technique.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
PROCEDURE	Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL	The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique). CycloMesh™ device (soaked in ropivacaine hydrochloride 10mg/mL) is positioned once the surgery for the inguinal hernia repair has been performed.
PROCEDURE	Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°°	The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique). CycloMesh™ device (soaked in saline solution) is positioned once the surgery for the inguinal hernia repair has been performed.

Timeline

• Start date: 2019-10-31
• Primary completion: 2022-03-16
• Completion: 2024-03-12
• First posted: 2019-07-25
• Last updated: 2025-03-20

Locations

1 site across 1 country: France