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)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Aesculap AG
- Enrollment
- 110
- Locations
- 5
- Primary Endpoint
- Surgical Site Infection (SSI) A2/A3 rate
Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •These include but are not limited to:
- •Vascular surgery
- •Colon and rectum
- •Hepatobiliary
- •Gastrointestinal
- •Gynecology
- •Abdominal Aortic Aneurysm (AAA) repair
- •Right hemicolectomy
Exclusion Criteria
- •Pregnancy
- •Breast feeding
- •Patients \< 18 years old or patients who are still in the growth phase
- •Contaminated and infected areas
- •Hypersensitivity to silver
- •Direct contact with the viscera
- •Previous allergic reactions to components of the device
- •Patient with previous laparotomy
- •Transverse laparotomy
- •Patients with previous hernia repair
Outcomes
Primary Outcomes
Surgical Site Infection (SSI) A2/A3 rate
Time Frame: at 6 months follow-up
SSIs remain a significant clinical problem as they are associated with substantial mortality and morbidity and impose severe demands on healthcare resources. Centers for Disease Control and Prevention Surgical Site Infection (SSI) Classification System differentiates Superficial SSI (A1), Deep Incisional SSI (A2) and Infection with involvement of organs/body cavities (A3). Only cases of A2 and A3 are considered for the Primary Outcome and are compared to rates from reference literature
Secondary Outcomes
- Cumulative Surgical Site Infection (SSI) A2/A3 rate during the study period(at 1 month, 1 year and 2 year follow-up.)
- Handling of the Optilene® Silver Mesh Elastic(intraoperatively)
- Length of hospital stay(at discharge (approximately up to 10 days after surgery))
- Time to return to work(at all postoperative examinations with a single value for each individual patient)
- Incisional hernia (IH) rate during the study period(repeatedly at 6 months, 1 year and 2 year follow-up.)
- Cumulative rate of of postoperative complications during the study period(at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up)
- Development of Pain: Visual Analogue Scale (VAS)(at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score)