Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction (PMCF_AWR)

Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Abdominal Wall Reconstruction: an Observational Prospective Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Hernia; Abdominal Wall Defect; Abdominal Wall Injury
• Intervention / Treatment: Device: CELLIS (Porcine Acellular Dermal Matrix, PADM)

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.

• Study Type: Observational
• Enrollment (Estimated): 112

Contacts and Locations

• Study Contact: Name: Guillaume HOFMANSKI; Phone Number: +33 (0)7 61 31 11 33; Email: guillaume.hofmanski@meccellis.com
• Study Contact Backup: Name: Claire CISTERNI, PhD; Phone Number: +33 (0)6 68 13 76 26; Email: claire.cisterni@meccellis.com

Study Locations

• France
  • Caen, France
    • Recruiting
    • CHU Caen Normandie, Service de Chirurgie Digestive
    • Contact: Gil LEBRETON, MD
    • Principal Investigator: Gil Lebreton, MD
  • La Rochelle, France
    • Recruiting
    • Groupe Hospitalier La Rochelle - Re - Aunis
    • Contact: Hélène GIBELIN, MD
    • Principal Investigator: Hélène GIBELIN, MD
  • Montpellier, France
    • Recruiting
    • CHU Montpellier, Hôpital Saint-Eloi, Pôle digestif, Service de Chirurgie Digestive B et Transplantation
    • Contact: Hassan BOUYABRINE, MD
    • Principal Investigator: Hassan BOUYABRINE, MD
  • Nantes, France, 44093
    • Recruiting
    • CHU Nantes Hôtel Dieu
    • Contact: Claire BLANCHARD-LOUIS, MD
    • Principal Investigator: Claire BLANCHARD-LOUIS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Meccellis Biotech
• Investigators: Principal Investigator: Hassan BOUYABRINE, MD, CHU Montpellier, France

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: abdominal wall reconstruction; biological mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: AWR_01_CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No