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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00981110
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : September 11, 2012
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Device: AQUAGEL Ag Hydrofiber Wound Dressing Device: Mepore Self-adhesive absorbent dressing Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : June 2008
Primary Completion Date : October 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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)



Primary Outcome Measures :
  1. The rate of patients with a Surgical site infection [ Time Frame: 30 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

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
Surgical Wound Infection
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Anti-Infective Agents
Anti-Bacterial Agents