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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)

Study acronym: SSIHLVER
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jun 2029 to Oct 2027 Start date: Mar 2026 to Sep 2026 · Completion date: Dec 2029 to Sep 2028v4 Show 2 more changesShow less
    • Start date: Mar 2026 to Sep 2026
    • Completion date: Dec 2029 to Sep 2028
  2. Primary completion date: May 2026 to Jun 2029 Start date: Aug 2025 to Mar 2026 · Completion date: May 2027 to Dec 2029v3 Show 2 more changesShow less
    • Start date: Aug 2025 to Mar 2026
    • Completion date: May 2027 to Dec 2029
  3. Start date: May 2025 to Aug 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Aesculap AG
32 trials monitored
See 6 trials at risk
Obesity
3,560 trials monitored
See 142 trials at risk
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.
Trial Details
NCT Number NCT06547138
Lead Sponsor Aesculap AG
Collaborators: B.Braun Surgical SA
Conditions Abdominal Aortic Aneurysm, Morbid Obesity
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov