NCT06547138

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

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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Prophylactic mesh	Prevention of incisional hernia after a prophylactic mesh in high-risk patients

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-06-01
• Completion: 2029-12-01
• First posted: 2024-08-09
• Last updated: 2025-08-28

Locations

5 sites across 1 country: Spain