Clinical trial NCT04947202: Clinical Study on the Safety of SAFIL® MESH
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Wall Defect
Ventral Hernia
Abdominal Hernia
Fascial Hernia
Keywords: Reinforcement of Soft Tissues
Hernioplasty
mesh repair
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2021-07-01
Enrollment: 152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Hernia rate
timeFrame: at one follow-up 12-30 months after initial intervention
Secondary outcomes:
measure: Intra-operative complications
timeFrame: intraoperatively
measure: Post-operative complications
timeFrame: at one follow-up 12-30 months after initial intervention
measure: Reintervention rate
timeFrame: at one follow-up 12-30 months after initial intervention
Other outcomes:
measure: Demographic data of the patient: age
timeFrame: preoperatively
measure: Demographic data of the patient: sex
timeFrame: preoperatively
measure: Demographic data of the patient: weight
timeFrame: preoperatively
measure: Demographic data of the patient: height
timeFrame: preoperatively
measure: Demographic data of the patient: general health status
timeFrame: preoperatively
measure: Demographic data of the patient: risk factors
timeFrame: preoperatively
measure: Surgery details: Type of intervention
timeFrame: intraoperative
measure: Surgery details: access
timeFrame: intraoperative
measure: Surgery details: anesthetics
timeFrame: intraoperative
measure: Surgery details: duration of surgery
timeFrame: intraoperative
measure: Surgery details: details on implanted mesh
timeFrame: intraoperative
measure: Surgery details: closure technology
timeFrame: intraoperative
Locations:
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Bizkaia
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
Study officials:
affiliation: Hospital Galdakao-Usansolo
name: Izaskun Badiola Bergara, Dr.
role: PRINCIPAL_INVESTIGATOR
References: