Clinical Study on the Safety of SAFIL® MESH

Aesculap AG152 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

152

Conditions

Abdominal Wall Defect Ventral Hernia Abdominal Hernia Fascial Hernia

Interventions

HernioplastyDEVICE

Hernioplasty is the repair of the defect using mesh patches.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (2)

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Outcomes

Primary Outcomes

Hernia rate

Rate of hernias occuring during follow-up of retrospectively included patients

Time frame: at one follow-up 12-30 months after initial intervention

Secondary Outcomes

Intra-operative complications

Retrospective documentation of Number of Participants with intraoperative Complications

Time frame: intraoperatively

Post-operative complications

Number of retrospectively included participants having complications during follow-up of

Time frame: at one follow-up 12-30 months after initial intervention

Reintervention rate

Complications leading to reintervention during follow-up of retrospectively included patients

Time frame: at one follow-up 12-30 months after initial intervention

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.