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The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material.
The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.
The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.
All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.
The study will be conducted in France in 3 investigational centres including 112 patients scheduled for an abdominal wall reconstruction.
Each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period.
Patients will return for ambulatory visits on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery.
CELLIS will be implanted by open technique following standard techniques. The membrane can be used in bridged or reinforced repairs. Mesh placement can include inlay (bridging), underlay intraperitoneal, sublay (retrorectus/retromuscular) positions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CELLIS (Porcine Acellular Dermal Matrix, PADM) | Device | Biological membrane used in abdominal reconstruction |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse events including reoperation and removal of the mesh. The main complications of interest are Surgical Site Occurrence (SSO) including Surgical Site Infection (SSI). | Percentage | From the surgical procedure throughout the entire 24-month follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recurrence/incisional hernia evaluated by clinical examination and/or CT-scan | Percentage | Throughout the study until end of the 24-month follow-up period |
| Rate of recurrence/incisional hernia requiring reoperation |
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Inclusion Criteria:
Exclusion Criteria:
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Adult with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan BOUYABRINE, MD | CHU Montpellier, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen Normandie, Service de Chirurgie Digestive | Caen | France | ||||
| Groupe Hospitalier La Rochelle - Ré - Aunis |
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| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Percentage
| Throughout the study until end of the 24-month follow-up period |
| Rate of abdominal wall laxity | Percentage | Throughout the study until end of the 24-month follow-up period |
| Description of device deficiency: inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling. | Summarized and listed | During the surgical procedure |
| La Rochelle |
| France |
| CHU Montpellier, Hôpital Saint-Eloi, Pôle digestif, Service de Chirurgie Digestive B et Transplantation | Montpellier | France |
| CHU Nantes Hôtel Dieu | Nantes | 44093 | France |