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

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.

Full Title of Study: “Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 2010

Interventions

  • Device: AQUAGEL Ag Hydrofiber Wound Dressing
    • Hydrofibre dressing containing ionic silver: medication performed as for frequency and duration according standard procedure
  • Device: Mepore Self-adhesive absorbent dressing
    • Standard dressing: medication performed as for frequency and duration according standard procedure

Arms, Groups and Cohorts

  • Active Comparator: Mepore Self-adhesive absorbent dressing
    • Mepore Self-adhesive absorbent dressing
  • Experimental: AQUAGEL Ag Hydrofiber Wound Dressing
    • AQUAGEL Ag Hydrofiber Wound Dressing

Clinical Trial Outcome Measures

Primary Measures

  • The rate of patients with a Surgical site infection
    • Time Frame: 30 days after surgery

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • European Institute of Oncology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bruno Andreoni, MD, Principal Investigator, European Institute of Oncology
    • Roberto Biffi, MD, Principal Investigator, European Institute of Oncology
    • Emilio Bertani, MD, Principal Investigator, European Institute of Oncolgy

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