Clinical Study on the Safety of SAFIL® MESH (SAFIL_MESH)

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

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

Study Overview

• Status: Completed
• Conditions: Ventral Hernia; Abdominal Hernia; Abdominal Wall Defect; Fascial Hernia
• Intervention / Treatment: Device: Hernioplasty

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 Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Bizkaia
    • Galdakao, Bizkaia, Spain, 48960
      • Hospital Galdakao-Usansolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Safil Mesh	Device: Hernioplasty; Hernioplasty is the repair of the defect using mesh patches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia rate	Rate of hernias occuring during follow-up of retrospectively included patients	at one follow-up 12-30 months after initial intervention

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data of the patient: age	Retrospective documentation of Demographic data of the patient for descriptive purposes: age of patients at time of surgery	preoperatively
Demographic data of the patient: sex	Retrospective documentation of Demographic data of the patient for descriptive purposes: sex	preoperatively
Demographic data of the patient: weight	Retrospective documentation of Demographic data of the patient for descriptive purposes: weight and height are documented to calculate body mass index	preoperatively
Demographic data of the patient: height	Retrospective documentation of Demographic data of the patient for descriptive purposes: weight and height are documented to calculate body mass index	preoperatively
Demographic data of the patient: general health status	Retrospective documentation of Demographic data of the patient for descriptive purposes: general health status according to ASA classification (ASA I: healthy patient; ASA II: A patient with mild systemic disease; ASA III: A patient with severe systemic disease; ASA IV: A patient with severe systemic disease that is a constant threat to life; ASA V: A moribund patient who is not expected to survive without the operation)	preoperatively
Demographic data of the patient: risk factors	Retrospective documentation of Demographic data of the patient for descriptive purposes: risk factors (smoker, alcohol abuse, previous surgery of abdominal hernia, chronic immunosuppression, chronic cortison treatment, abdominal aortic aneurysm, anticoagulantic treatment)	preoperatively
Surgery details: Type of intervention	Retrospective documentation of surgery details for descriptive purposes: Type of intervention (elective / emergency)	intraoperative
Surgery details: access	Retrospective documentation of surgery details for descriptive purposes: access (open / laparoscopic / laparoscopic with conversion)	intraoperative
Surgery details: anesthetics	Retrospective documentation of surgery details for descriptive purposes: anesthetics (general / regional / local)	intraoperative
Surgery details: duration of surgery	Retrospective documentation of surgery details for descriptive purposes: duration of surgery	intraoperative
Surgery details: details on implanted mesh	Retrospective documentation of surgery details for descriptive purposes: details on implanted mesh (number / sizes)	intraoperative
Surgery details: closure technology	Retrospective documentation of surgery details for descriptive purposes: closure technology (absorbable suture, non absorbable suture, single-knot, continuous suture, adhesives)	intraoperative

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Izaskun Badiola Bergara, Dr., Hospital Galdakao-Usansolo

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: mesh repair; Hernioplasty; Reinforcement of Soft Tissues
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Ventral; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: AAG-O-H-2040

Drug and device information, study documents

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