Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery

European Institute of Oncology120 enrolled

Overview

The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site infections (SSI) in patients who underwent colorectal resection for malignancy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Colorectal Cancer

Interventions

AQUAGEL Ag Hydrofiber Wound DressingDEVICE

Hydrofibre dressing containing ionic silver: medication performed as for frequency and duration according standard procedure

Mepore Self-adhesive absorbent dressingDEVICE

Standard dressing: medication performed as for frequency and duration according standard procedure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients bearing solid tumours who are candidate to open radical surgery for colorectal cancer (histology proven) * Age 18-75 * Informed signed consent * Performance Status 0-2 (according to ECOG score) * Platelets \> 50.000/mm3 * Prothrombin Time (Quick) \> 60% * White Blood Cells \> 2500/mm3 * Life Expectancy \> 3 months Exclusion Criteria: * Intestinal obstruction * Severe intestinal bleeding requiring blood transfusion * Age under 18 or over 75 * Severe hepatic failure (ascites, portal hypertension, jaundice or encephalopathy) * Renal failure (hemodialysis, creatinin \> 2.5 mg/dL) * Active infections * Coagulopathy * Inability to give an informed consent * Known allergies to dressing components

Locations (2)

S. Gerardo Hospital

Monza, Monza, Italy

European Institute of Oncology

Milan, Italy

Outcomes

Primary Outcomes

The rate of patients with a Surgical site infection

Time frame: 30 days after surgery

Data from ClinicalTrials.gov

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