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Completed

NCT Number: NCT04947202

Clinical Study on the Safety of 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

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Key information

Conditions

Abdominal Wall Defect Abdominal Hernia Fascial Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ventral Hernia

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Galdakao-Usansolo, Galdakao, Bizkaia, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hernioplasty

Device

Hernioplasty is the repair of the defect using mesh patches.

Primary outcomes

  1. Hernia rate

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

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

Secondary outcomes

  1. Intra-operative complications

    Time frame: intraoperatively

    Retrospective documentation of Number of Participants with intraoperative Complications

  2. Post-operative complications

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

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

  3. Reintervention rate

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

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

Other outcomes

  1. Demographic data of the patient: age

    Time frame: preoperatively

    Retrospective documentation of Demographic data of the patient for descriptive purposes: age of patients at time of surgery

  2. Demographic data of the patient: sex

    Time frame: preoperatively

    Retrospective documentation of Demographic data of the patient for descriptive purposes: sex

  3. Demographic data of the patient: weight

    Time frame: preoperatively

    Retrospective documentation of Demographic data of the patient for descriptive purposes: weight and height are documented to calculate body mass index

  4. Demographic data of the patient: height

    Time frame: preoperatively

    Retrospective documentation of Demographic data of the patient for descriptive purposes: weight and height are documented to calculate body mass index

  5. Demographic data of the patient: general health status

    Time frame: preoperatively

    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)

  6. Demographic data of the patient: risk factors

    Time frame: preoperatively

    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)

  7. Surgery details: Type of intervention

    Time frame: intraoperative

    Retrospective documentation of surgery details for descriptive purposes:

    Type of intervention (elective / emergency)

  8. Surgery details: access

    Time frame: intraoperative

    Retrospective documentation of surgery details for descriptive purposes:

    access (open / laparoscopic / laparoscopic with conversion)

  9. Surgery details: anesthetics

    Time frame: intraoperative

    Retrospective documentation of surgery details for descriptive purposes:

    anesthetics (general / regional / local)

  10. Surgery details: duration of surgery

    Time frame: intraoperative

    Retrospective documentation of surgery details for descriptive purposes:

    duration of surgery

  11. Surgery details: details on implanted mesh

    Time frame: intraoperative

    Retrospective documentation of surgery details for descriptive purposes:

    details on implanted mesh (number / sizes)

  12. Surgery details: closure technology

    Time frame: intraoperative

    Retrospective documentation of surgery details for descriptive purposes:

    closure technology (absorbable suture, non absorbable suture, single-knot, continuous suture, adhesives)

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study 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

Acronym: SAFIL_MESH

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 1, 2021
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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