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NOT YET RECRUITING
NCT06547138

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

Sponsor: Aesculap AG

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

110

Start Date

2026-03

Completion Date

2029-12

Last Updated

2025-08-28

Healthy Volunteers

No

Interventions

DEVICE

Prophylactic mesh

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

Locations (5)

Hospital Universitari Germans Tries i Pujol

Badalona, Spain

Hospital Municipal Badalona

Badalona, Spain

Hospital Comarcal Sant Jaume de Calella

Calella, Spain

Hospital de Mataró

Mataró, Spain

Hospital Fundació Esperit Sant

Santa Coloma de Gramenet, Spain