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| Name | Class |
|---|---|
| Cousin Biotech | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL | Experimental | 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. |
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| CycloMesh™ soaked in saline solution 9°/°° | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS). | The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate. It is a self-assessment scale and is sensitive, reproducible, reliable and validated for both acute and chronic pain situations. Pain assessment will be performed 6 hours after implant placement and during cough effort. | 6 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity back to home (Day 0) and Day 1 to 3 will be assessed using a Visual Analogic Scale (VAS) | Pain intensity will be reported by the patient on a log book using a Visual Analogic Scale . The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate | Back to home (Day 0) at 8pm and 10 pm, Twice a day (8 am and 8 pm) at Day 1, Day 2 and Day 3 |
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Inclusion Criteria:
Disease-related criteria:
Population-related criteria:
Non inclusion Criteria:
Disease-related criteria:
Product or device-related criteria:
Population-related criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens Picardie university hospital | Amiens | 80054 | France |
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The patient will be blinded to the randomisation arm. As the procedure is conducted under general anaesthesia, the patient will not be informed whether the procedure which was performed on him/her did or did not result in the implantation of the CycloMesh™ device. Also, the surgeon such as the outcome assessor will be blinded to the randomisation arm
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| Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°° | Procedure | 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. |
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| Pain intensity at Day 1 and Day 7 post-surgery will be assessed using a Visual Analogic Scale (VAS) | Pain intensity at Day 1 and Day 7 post-surgery will be assessed using a visual analogic scale and during a telephone interview performed by an investigator's collaborator. The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate.It is a self-assessment scale and is sensitive, reproducible, reliable and validated both in acute pain and chronic pain situations. | Day 1 and Day 7 post-surgery |
| Pain intensity at 1 month post-surgery will be assessed using a Visual Analogic Scale (VAS) | Pain intensity at 1 month post-surgery will be assessed, using a visual analogic scale, during a visit to the surgeon and in 3 different situations: at rest, walking and during cough effort.The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate.It is a self-assessment scale and is sensitive, reproducible, reliable and validated both in acute pain and chronic pain situations. | 1 month post-surgery |
| Hospitalization lenght (in hours) | In case of delayed discharge (the day after the surgery or prolongation of hospitalization), the reasons of prolonged hospital treatment will be collected | 1 week post-surgery |
| Duration of surgical time from the first incision until wound closure (in minutes) | Duration of surgical time from the first incision until wound closure will be calculated in minutes | At the moment of wound closure |
| Evolution between inclusion and 24 months post-surgery with regard to quality of life | Quality of life will be assessed using the 36-item Short Form Health Survey (SF-36) score at inclusion and 1 month post-surgery: SF-36 is a standardized and validated questionnaire assessing quality of life. The SF-36 provides two scores: a mental and social quality of life score and a physical quality of life score | Inclusion and 1 month post-surgery 12 and 24 months post-surgery |
| The amount of consumed analgesic will be assessed using post-operative data and data reported by the patient on a log book | The amount of consumed analgesic will be measured by calculating the number of patients who have consumed analgesic during the 7 post-operative and antalgic intake (in mg) during the 7 post-operative | 7 days post-surgery period |
| Time to return to work or activity post-surgery | The Time to return to work or activity following surgery will be evaluated in terms of the number of days between hospitalisation and resumption of activity | Day 1, Day 7 and 1 month post-surgery |
| The rate of early recurrence (at 1 month postoperative) and at long term (12 and 24 months) will be assessed | Rates of early reccurence during the study (up to one month after surgery). The long-term recurrence rate will also be assessed at 12 and 24 months post-operatively. Recurrence is defined as the reappearance of the hernia on the same side as the one initially operated on, whether the recurrence required surgical intervention. | All study period (24-months) |
| Number of patients presenting at least one adverse event (AE) | The safety and tolerability end points will be will be as follows: number of patients presenting at least one adverse event (AE) | All study period (24-months) |
| Number of patients presenting at least one AE related to the the device implantation | The safety and tolerability end points will be will be as follows: number of patients presenting at least one AE related to the the device implantation | All study period (24-months) |
| Number of patients presenting at least one serious adverse event (SAE) | The safety and tolerability end points will be will be as follows: number of patients presenting at least one serious adverse event (SAE) | All study period (24-months) |
| Total number of AE related to the device implantation, classified by type and organ | The safety and tolerability end points will be will be as follows: total number of AE related to the device implantation, classified by type and organ | All study period (24-months) |
| Satisfaction of the surgeon and unit staff regarding the use of CycloMesh will be evaluated using a satisfaction questionnaire | Surgeon and unit staff will have to answer to a questionnaire concerning the packaging of CycloMesh, the technical characteristics of the implant (flexibility, porosity, etc.), its size, time imbibition of CycloMesh, etc. | Day 0 |
| Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS). | The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate. It is a self-assessment scale and is sensitive, reproducible, reliable and validated for both acute and chronic pain situations. Pain assessment will be performed 6 hours after implant placement at rest and walking | 6 hours post-surgery |
| The rate of patient with chronic pain at 12 and 24 months | Chronic pain is defined as pain that lasts for at least 6 months after surgery | 12-months after surgery and 24-months after surgery |
| The rate of implant migration at 12 and 24 months | Migration is defined as the movement of the entire implant into an organ. | 12-months after surgery and 24-months after surgery |
| The rate of foreign body sensation at 12 and 24 months postoperative | Foreign body sensation is assessed by answering yes or no to the question: do you feel a foreign body in the groin | 12-months after surgery and 24-months after surgery |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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