Clinical Study on the Safety of SAFIL® MESH

Completed

• Conditions: Abdominal Wall Defect; Ventral Hernia; Abdominal Hernia; Fascial Hernia
• Interventions: Device: Hernioplasty

• Registration Number: NCT04947202
• Lead Sponsor: Aesculap AG

Brief Summary

Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects

Detailed Description

The study design is a retrospective case-note series of patients that have undergone reinforcement of soft tissues with Safil® Mesh after abdominal wall surgery or other fascial defects between the period January 2019 - November 2020

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-23
• Study Start: 2021-07-01
• Study First Posted: 2021-07-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh

Exclusion Criteria

• No exclusion criteria have been set.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Safil Mesh	Hernioplasty	-

Primary Outcome Measures

Name	Time	Method
Hernia rate	at one follow-up 12-30 months after initial intervention	Rate of hernias occuring during follow-up of retrospectively included patients

Secondary Outcome Measures

Name	Time	Method
Intra-operative complications	intraoperatively	Retrospective documentation of Number of Participants with intraoperative Complications
Post-operative complications	at one follow-up 12-30 months after initial intervention	Number of retrospectively included participants having complications during follow-up of
Reintervention rate	at one follow-up 12-30 months after initial intervention	Complications leading to reintervention during follow-up of retrospectively included patients

Trial Locations

Locations (2)

Hospital Galdakao-Usansolo; 🇪🇸 Galdakao, Bizkaia, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain