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

N/ANot Yet RecruitingNCT06547138

Aesculap AG110 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

110

Conditions

Abdominal Aortic Aneurysm Morbid Obesity

Interventions

Prophylactic meshDEVICE

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

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Surgical Site Infection (SSI) A2/A3 rate

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

Time frame: at 6 months follow-up

Secondary Outcomes

Cumulative rate of of postoperative complications during the study period

Numbers of all postoperative complications such as mortality, burst abdomen, bowel obstruction, bulging, necrosis, fistula, wound dehiscence, hematoma, seroma, peritonitis are added to the overall complication rate that is observed over the postoperative course

Time frame: at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up

Cumulative Surgical Site Infection (SSI) A2/A3 rate during the study period

Number of the Surgical Site Infection (SSI) (only A2 and A3) rate at every follow-up

Time frame: at 1 month, 1 year and 2 year follow-up.

Incisional hernia (IH) rate during the study period

Incisional hernia (IH) is a protrusion of tissue that forms at the site of a healing surgical scar. Incisional hernia refers to abdominal wall hernia at the site of a previous surgical incision.

Time frame: repeatedly at 6 months, 1 year and 2 year follow-up.

Length of hospital stay

Number of days the patient has to stay in hospital after the surgery

Time frame: at discharge (approximately up to 10 days after surgery)

Development of Pain: Visual Analogue Scale (VAS)

This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".

Time frame: at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score

Time to return to work

The number of days needed to return to work after the surgery of the individual patient is documented

Time frame: at all postoperative examinations with a single value for each individual patient

Handling of the Optilene® Silver Mesh Elastic

The handling will be evaluated using a questionnaire (Likert-type scale) with the dimensions Tensile Strength, Absence of memory effect, Elasticity, Stiffness, Surface weight, Thickness, Ease of being fixed with suture, Ease of package extraction as well as an overall opinion in five evaluation levels (excellent=1, very good=2, good=3, satisfied=4, poor=5)

Time frame: intraoperatively