Abdominal Aortic AneurysmSSIHLVERNCT06547138
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
An observational study of Abdominal Aortic Aneurysm and Morbid Obesity, run by Aesculap AG at 5 sites in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Morbid Obesity
- What is being tested?
- Prophylactic mesh
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 5 sitesSpain
- Study dates
- Sep 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites
Hospital Universitari Germans Tries i Pujol
Badalona, 08916
Joan Francesc Julián, Dr.
Joan Francesc Julián, Dr.
Hospital Municipal Badalona
Badalona
Jorge Marroquin, Dr.
Jorge Marroquin, Dr.
Hospital Comarcal Sant Jaume de Calella
Calella, 08370
Paqui Vasco, Dr.
Paqui Vasco, Dr.
Hospital de Mataró
Mataró, 08304
Berhanu Chimdi, Dr.
Berhanu Chimdi, Dr.
Hospital Fundació Esperit Sant
Santa Coloma de Gramenet, 08923
Daniel Troyano Escribano, Dr.
Daniel Troyano Escribano, Dr.
About this study
Official title: 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.
- Conditions
- Abdominal Aortic Aneurysm, Morbid Obesity
- Being tested
- Prophylactic mesh
- Keywords
- urgent, primary median laparotomy
- Medical subject headings
- Aortic Aneurysm, Abdominal, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic meshDevice
Prevention of incisional hernia after a prophylactic mesh in high-risk patients
| Study group | Role | What they receive |
|---|---|---|
| Optilene® Silver Mesh Elastic | Prophylactic mesh in high-risk patients Receives: Device: Prophylactic mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (SSI) A2/A3 rate
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
Measured: at 6 months follow-up
Secondary outcomes (7)
Cumulative rate of of postoperative complications during the study period
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
Measured: 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
Number of the Surgical Site Infection (SSI) (only A2 and A3) rate at every follow-up
Measured: at 1 month, 1 year and 2 year follow-up.
Incisional hernia (IH) rate during the study period
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.
Measured: repeatedly at 6 months, 1 year and 2 year follow-up.
Length of hospital stay
Number of days the patient has to stay in hospital after the surgery
Measured: at discharge (approximately up to 10 days after surgery)
Development of Pain: Visual Analogue Scale (VAS)
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".
Measured: 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
The number of days needed to return to work after the surgery of the individual patient is documented
Measured: at all postoperative examinations with a single value for each individual patient
Handling of the Optilene® Silver Mesh Elastic
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)
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study startSep 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Daniel Troyano Escribano, Dr., Principal investigator, Fundació Hospital de l'Esperit Sant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547138
- Sponsor's protocol ID
- AAG-G-H-2126
- Acronym
- SSIHLVER
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06547138
- Acronym / sponsor ID
- SSIHLVER / AAG-G-H-2126
- Conditions
- Abdominal Aortic Aneurysm, Morbid Obesity
- Keywords
- urgent, primary median laparotomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optilene® Silver Mesh Elastic | – | Device: Prophylactic meshProphylactic mesh in high-risk patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (19 listed)
- 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.
- Vascular surgery
- Colon and rectum
- Hepatobiliary
Key exclusion criteria (17 listed)
- Pregnancy
- Breast feeding
- Patients < 18 years old or patients who are still in the growth phase
- Contaminated and infected areas
- Hypersensitivity to silver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic meshPrevention of incisional hernia after a prophylactic mesh in high-risk patients | Device | Optilene® Silver Mesh Elastic |
Primary outcome
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
7 secondary outcomes
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
Cumulative Surgical Site Infection (SSI) A2/A3 rate during the study period
Time frame: 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.
Length of hospital stay
Time frame: 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
Time to return to work
Time frame: at all postoperative examinations with a single value for each individual patient
Handling of the Optilene® Silver Mesh Elastic
Time frame: intraoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Troyano Escribano, Dr. principal investigator
Fundació Hospital de l'Esperit Sant
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Morbid Obesity, run by Aesculap AG at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene Fita Esteban (+34609054401, info@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (SSI) A2/A3 rate (time frame: at 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.