Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH) (SSIHLVER)

June 1, 2026 updated by: Aesculap AG

Prospective Descriptive Multicentre Pilot Study On The Effectiveness and Safety Of Optilene® Silver Mesh Elastic In Prevention Of Surgical Site Infection (SSI) And Incisional Hernia (IH)

The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on the SSI rates, IH rates and overall clinical performance of Optilene® Silver Mesh Elastic used for the prevention of incisional hernia as prophylactic mesh in patients that require urgent median laparotomy in clinical routine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Irene Fita Esteban
  • Phone Number: +34609054401
  • Email: info@bbraun.com

Study Contact Backup

  • Name: José Manuel Molina Villar
  • Phone Number: +34697502623
  • Email: info@bbraun.com

Study Locations

  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Tries i Pujol
        • Contact:
          • Joan Francesc Julián, Dr.
        • Principal Investigator:
          • Joan Francesc Julián, Dr.
      • Badalona, Spain
        • Hospital Municipal Badalona
        • Contact:
          • Jorge Marroquin, Dr.
        • Principal Investigator:
          • Jorge Marroquin, Dr.
      • Calella, Spain, 08370
        • Hospital Comarcal Sant Jaume de Calella
        • Contact:
          • Paqui Vasco, Dr.
        • Principal Investigator:
          • Paqui Vasco, Dr.
      • Mataró, Spain, 08304
        • Hospital de Mataró
        • Contact:
          • Berhanu Chimdi, Dr.
        • Principal Investigator:
          • Berhanu Chimdi, Dr.
      • Santa Coloma de Gramenet, Spain, 08923
        • Hospital Fundació Esperit Sant
        • Contact:
          • Daniel Troyano Escribano, Dr.
        • Principal Investigator:
          • Daniel Troyano Escribano, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

High-risk patients according to the professional criteria (such as but not limited to: age, nutrition, body mass index, comorbidities, etc.) who are undergoing prophylactic mesh implantation to avoid surgical site infection after an emergency or urgent intra-abdominal laparotomy.

Description

Inclusion Criteria:

  • Adult patients (18 years or older)
  • Surgical procedure requiring urgent, primary median laparotomy, which are classified as "Class III/Contaminated" or "Class IV/Dirty-Infected" regarding the CDC classification.

These include but are not limited to:

  • Vascular surgery
  • Colon and rectum
  • Hepatobiliary
  • Gastrointestinal
  • Gynecology
  • Urology
  • Abdominal Aortic Aneurysm (AAA) repair
  • Right hemicolectomy
  • Left hemicolectomy
  • Sigmoidectomy
  • Anterior resection
  • Abdominoperineal amputation
  • Exploratory laparotomy
  • Cholecystectomy

  • Cholecystectomy and choledocotomy

    • Written informed consent

Exclusion Criteria:

  • Pregnancy
  • Breast feeding
  • Patients < 18 years old or patients who are still in the growth phase
  • Contaminated and infected areas
  • Hypersensitivity to silver
  • Direct contact with the viscera
  • Previous allergic reactions to components of the device
  • Patient with previous laparotomy
  • Transverse laparotomy
  • Patients with previous hernia repair
  • Simultaneous participation in another investigational clinical trial (drug or medical studies)
  • Patients with active oncologic treatment (chemo and radiotherapy)
  • Underlying autoimmune disease
  • Recent cardiovascular complication
  • Gynecology surgery
  • Urology surgery
  • Vascular surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Optilene® Silver Mesh Elastic
Prophylactic mesh in high-risk patients
Device: Prophylactic mesh
Prevention of incisional hernia after a prophylactic mesh in high-risk patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgical Site Infection (SSI) A2/A3 rate
Time Frame: at 6 months follow-up
SSIs remain a significant clinical problem as they are associated with substantial mortality and morbidity and impose severe demands on healthcare resources. Centers for Disease Control and Prevention Surgical Site Infection (SSI) Classification System differentiates Superficial SSI (A1), Deep Incisional SSI (A2) and Infection with involvement of organs/body cavities (A3). Only cases of A2 and A3 are considered for the Primary Outcome and are compared to rates from reference literature
at 6 months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative rate of of postoperative complications during the study period
Time Frame: at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up
Numbers of all postoperative complications such as mortality, burst abdomen, bowel obstruction, bulging, necrosis, fistula, wound dehiscence, hematoma, seroma, peritonitis are added to the overall complication rate that is observed over the postoperative course
at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up
Cumulative Surgical Site Infection (SSI) A2/A3 rate during the study period
Time Frame: at 1 month, 1 year and 2 year follow-up.
Number of the Surgical Site Infection (SSI) (only A2 and A3) rate at every follow-up
at 1 month, 1 year and 2 year follow-up.
Incisional hernia (IH) rate during the study period
Time Frame: repeatedly at 6 months, 1 year and 2 year follow-up.
Incisional hernia (IH) is a protrusion of tissue that forms at the site of a healing surgical scar. Incisional hernia refers to abdominal wall hernia at the site of a previous surgical incision.
repeatedly at 6 months, 1 year and 2 year follow-up.
Length of hospital stay
Time Frame: at discharge (approximately up to 10 days after surgery)
Number of days the patient has to stay in hospital after the surgery
at discharge (approximately up to 10 days after surgery)
Development of Pain: Visual Analogue Scale (VAS)
Time Frame: at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".
at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score
Time to return to work
Time Frame: at all postoperative examinations with a single value for each individual patient
The number of days needed to return to work after the surgery of the individual patient is documented
at all postoperative examinations with a single value for each individual patient
Handling of the Optilene® Silver Mesh Elastic
Time Frame: intraoperatively
The handling will be evaluated using a questionnaire (Likert-type scale) with the dimensions Tensile Strength, Absence of memory effect, Elasticity, Stiffness, Surface weight, Thickness, Ease of being fixed with suture, Ease of package extraction as well as an overall opinion in five evaluation levels (excellent=1, very good=2, good=3, satisfied=4, poor=5)
intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aesculap AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
B.Braun Surgical SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Troyano Escribano, Dr., Fundació Hospital de l'Esperit Sant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAG-G-H-2126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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