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NCT Number: NCT06547138

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Municipal Badalona, Badalona, Spain

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Prophylactic mesh

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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".

  6. 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

  7. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Fita Esteban

CONTACT

[email protected]

+34609054401

José Manuel Molina Villar

CONTACT

[email protected]

+34697502623

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study 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)

Acronym: SSIHLVER

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 9, 2024
Registry last updated
Jun 2, 2026

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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