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

NCT06547138 | Not Yet Recruiting

• 1 other identifier: AAG-G-H-2126
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 5

Brief 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 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

Keywords

urgent, primary median laparotomy

Outcome Measures

Primary Outcomes (1)

• 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

  at 6 months follow-up

Secondary Outcomes (7)

• Cumulative rate of of postoperative complications during the study period

  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

  at 1 month, 1 year and 2 year follow-up.

• Incisional hernia (IH) rate during the study period

  repeatedly at 6 months, 1 year and 2 year follow-up.

• Length of hospital stay

  at discharge (approximately up to 10 days after surgery)

• Development of Pain: Visual Analogue Scale (VAS)

  at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score

Study Arms (1)

Optilene® Silver Mesh Elastic

Prophylactic mesh in high-risk patients

Device: Prophylactic mesh

Interventions

Prophylactic mesh DEVICE

Prevention of incisional hernia after a prophylactic mesh in high-risk patients

Optilene® Silver Mesh Elastic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesculap AG: lead
• B.Braun Surgical SA: collaborator

Study Sites (5)

Hospital Universitari Germans Tries i Pujol

Badalona, 08916, Spain

Location

Hospital Municipal Badalona

Badalona, Spain

Location

Hospital Comarcal Sant Jaume de Calella

Calella, 08370, Spain

Location

Hospital de Mataró

Mataró, 08304, Spain

Location

Hospital Fundació Esperit Sant

Santa Coloma de Gramenet, 08923, Spain

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Obesity, Morbid

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Troyano Escribano, Dr.

  Fundació Hospital de l'Esperit Sant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Fita Esteban

CONTACT

+34609054401; info@bbraun.com

José Manuel Molina Villar

CONTACT

+34697502623; info@bbraun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)