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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT00981110
First received: August 31, 2009
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Device: AQUAGEL Ag Hydrofiber Wound Dressing
Device: Mepore Self-adhesive absorbent dressing
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by European Institute of Oncology:

Primary Outcome Measures:
  • The rate of patients with a Surgical site infection [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mepore Self-adhesive absorbent dressing
Mepore Self-adhesive absorbent dressing
 Device: Mepore Self-adhesive absorbent dressing
Standard dressing: medication performed as for frequency and duration according standard procedure
Other Name: Mepore Self-adhesive absorbent dressing
Experimental: AQUAGEL Ag Hydrofiber Wound Dressing
AQUAGEL Ag Hydrofiber Wound Dressing
 Device: AQUAGEL Ag Hydrofiber Wound Dressing
Hydrofibre dressing containing ionic silver: medication performed as for frequency and duration according standard procedure
Other Name: AQUAGEL Ag Hydrofiber Wound Dressing (ConvaTee,US)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981110

Locations
Italy
European Institute of Oncology
Milan, Italy
S. Gerardo Hospital
Monza, Italy, 20052
Sponsors and Collaborators
European Institute of Oncology
Investigators
Principal Investigator: Bruno Andreoni, MD European Institute of Oncology
Principal Investigator: Roberto Biffi, MD European Institute of Oncology
Principal Investigator: Emilio Bertani, MD European Institute of Oncolgy
  More Information

No publications provided by European Institute of Oncology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT00981110     History of Changes
Other Study ID Numbers: IEO S402/208
Study First Received: August 31, 2009
Last Updated: September 10, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by European Institute of Oncology:
Surgical site infections (SSI)
Advanced antimicrobial dressing and clean surgery
Hydrofibre dressing

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013