Clinical trial NCT06547138: Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
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)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Abdominal Aortic Aneurysm
Morbid Obesity
Keywords: urgent, primary median laparotomy
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2024-08-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High-risk patients according to the professional criteria (such as but not limited to: age, nutrition, body mass index, comorbidities, etc.) who are undergoing prophylactic mesh implantation to avoid surgical site infection after an emergency or urgent intra-abdominal laparotomy.

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.


Eligibility criteria: 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
* Urology
* Abdominal Aortic Aneurysm (AAA) repair
* Right hemicolectomy
* Left hemicolectomy
* Sigmoidectomy
* Anterior resection
* Abdominoperineal amputation
* Exploratory laparotomy
* Cholecystectomy
* Cholecystectomy and choledocotomy

  * Written informed consent

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
* Simultaneous participation in another investigational clinical trial (drug or medical studies)
* Patients with active oncologic treatment (chemo and radiotherapy)
* Underlying autoimmune disease
* Recent cardiovascular complication
* Gynecology surgery
* Urology surgery
* Vascular surgery

Primary outcomes:
measure: Surgical Site Infection (SSI) A2/A3 rate
timeFrame: at 6 months follow-up
Secondary outcomes:
measure: Cumulative rate of of postoperative complications during the study period
timeFrame: at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up
measure: Cumulative Surgical Site Infection (SSI) A2/A3 rate during the study period
timeFrame: at 1 month, 1 year and 2 year follow-up.
measure: Incisional hernia (IH) rate during the study period
timeFrame: repeatedly at 6 months, 1 year and 2 year follow-up.
measure: Length of hospital stay
timeFrame: at discharge (approximately up to 10 days after surgery)
measure: Development of Pain: Visual Analogue Scale (VAS)
timeFrame: at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score
measure: Time to return to work
timeFrame: at all postoperative examinations with a single value for each individual patient
measure: Handling of the Optilene® Silver Mesh Elastic
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Tries i Pujol
city: Badalona
country: Spain
facility: Hospital Municipal Badalona
city: Calella
country: Spain
facility: Hospital Comarcal Sant Jaume de Calella
city: Mataró
country: Spain
facility: Hospital de Mataró
city: Santa Coloma De Gramenet
country: Spain
facility: Hospital Fundació Esperit Sant
Study officials:
affiliation: Fundació Hospital de l'Esperit Sant
name: Daniel Troyano Escribano, Dr.
role: PRINCIPAL_INVESTIGATOR
References: