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

NCT06547138 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2025-08-28

No results posted yet for this study

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

Interventions

DEVICE

Prophylactic mesh

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

Sponsors & Collaborators

  • B.Braun Surgical SA

    collaborator INDUSTRY

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Daniel Troyano Escribano, Dr. · Fundació Hospital de l'Esperit Sant

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2029-06-30
Completion
2029-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06547138 on ClinicalTrials.gov