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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAesculap AG

About this trial

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.

Eligibility criteria

Qualifiers

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.

Vascular surgery

Colon and rectum

Disqualifiers

Pregnancy

Breast feeding

Patients < 18 years old or patients who are still in the growth phase

Contaminated and infected areas

Trial design

Treatments tested in this trial

  • Prophylactic mesh

Treatment groups

110 Participants
are divided into 1 treatment group

Sponsors and collaborators

Aesculap AG

Lead sponsor

B.Braun Surgical SA

Collaborator