Clinical trial NCT04580511: Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction
Official title: Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Abdominal Wall Reconstruction: an Observational Prospective Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Abdominal Wall Defect
Abdominal Wall Injury
Abdominal Hernia
Keywords: abdominal wall reconstruction
biological mesh
Lead sponsor: Meccellis Biotech
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient aged ≥18 years,
* Patient with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure,
* Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
* Patient being informed of the porcine origin of the device in advance of the procedure.

Exclusion Criteria:

* Patient with known hypersensitivity to porcine materials,
* Patient who is pregnant,
* Patient having refused to participate to the study,
* Patient refusing to return for the follow-up visits.

Primary outcomes:
measure: 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).
timeFrame: From the surgical procedure throughout the entire 24-month follow-up period
Secondary outcomes:
measure: Rate of recurrence/incisional hernia evaluated by clinical examination and/or CT-scan
timeFrame: Throughout the study until end of the 24-month follow-up period
measure: Rate of recurrence/incisional hernia requiring reoperation
timeFrame: Throughout the study until end of the 24-month follow-up period
measure: Rate of abdominal wall laxity
timeFrame: Throughout the study until end of the 24-month follow-up period
measure: 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.
timeFrame: During the surgical procedure
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie, Service de Chirurgie Digestive
city: La Rochelle
country: France
facility: Groupe Hospitalier La Rochelle - Ré - Aunis
city: Montpellier
country: France
facility: CHU Montpellier, Hôpital Saint-Eloi, Pôle digestif, Service de Chirurgie Digestive B et Transplantation
city: Nantes
country: France
facility: CHU Nantes Hôtel Dieu
Study officials:
affiliation: CHU Montpellier, France
name: Hassan BOUYABRINE, MD
role: PRINCIPAL_INVESTIGATOR
References: