NCT04947202

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

June 16, 2021

Last Update Submit

January 19, 2022

Conditions

Abdominal Wall DefectVentral HerniaAbdominal HerniaFascial Hernia

Keywords

Reinforcement of Soft TissuesHernioplastymesh repair

Outcome Measures

Primary Outcomes (1)

  • Hernia rate

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

    at one follow-up 12-30 months after initial intervention

Secondary Outcomes (3)

  • Intra-operative complications

    intraoperatively

  • Post-operative complications

    at one follow-up 12-30 months after initial intervention

  • Reintervention rate

    at one follow-up 12-30 months after initial intervention

Other Outcomes (12)

  • Demographic data of the patient: age

    preoperatively

  • Demographic data of the patient: sex

    preoperatively

  • Demographic data of the patient: weight

    preoperatively

  • +9 more other outcomes

Study Arms (1)

Safil Mesh

Device: Hernioplasty

Interventions

HernioplastyDEVICE

Hernioplasty is the repair of the defect using mesh patches.

Safil Mesh

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, 48960, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Hernia, VentralHernia, Abdominal

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Officials

  • Izaskun Badiola Bergara, Dr.

    Hospital Galdakao-Usansolo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2021

First Posted

July 1, 2021

Study Start

July 1, 2021

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

January 24, 2022

Record last verified: 2022-01

Locations

ES(2)