Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery (AM)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
AQUAGEL Ag Hydrofiber Wound Dressing
Mepore Self-adhesive absorbent dressing
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Surgical site infections (SSI), Advanced antimicrobial dressing and clean surgery, Hydrofibre dressing
Eligibility 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
Sites / Locations
- European Institute of Oncology
- S. Gerardo Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mepore Self-adhesive absorbent dressing
AQUAGEL Ag Hydrofiber Wound Dressing
Arm Description
Mepore Self-adhesive absorbent dressing
AQUAGEL Ag Hydrofiber Wound Dressing
Outcomes
Primary Outcome Measures
The rate of patients with a Surgical site infection
Secondary Outcome Measures
Full Information
NCT ID
NCT00981110
First Posted
August 31, 2009
Last Updated
September 10, 2012
Sponsor
European Institute of Oncology
1. Study Identification
Unique Protocol Identification Number
NCT00981110
Brief Title
Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery
Acronym
AM
Official Title
Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Institute of Oncology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Surgical site infections (SSI), Advanced antimicrobial dressing and clean surgery, Hydrofibre dressing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mepore Self-adhesive absorbent dressing
Arm Type
Active Comparator
Arm Description
Mepore Self-adhesive absorbent dressing
Arm Title
AQUAGEL Ag Hydrofiber Wound Dressing
Arm Type
Experimental
Arm Description
AQUAGEL Ag Hydrofiber Wound Dressing
Intervention Type
Device
Intervention Name(s)
AQUAGEL Ag Hydrofiber Wound Dressing
Other Intervention Name(s)
AQUAGEL Ag Hydrofiber Wound Dressing (ConvaTee,US)
Intervention Description
Hydrofibre dressing containing ionic silver: medication performed as for frequency and duration according standard procedure
Intervention Type
Device
Intervention Name(s)
Mepore Self-adhesive absorbent dressing
Intervention Description
Standard dressing: medication performed as for frequency and duration according standard procedure
Primary Outcome Measure Information:
Title
The rate of patients with a Surgical site infection
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Andreoni, MD
Organizational Affiliation
European Institute of Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Biffi, MD
Organizational Affiliation
European Institute of Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emilio Bertani, MD
Organizational Affiliation
European Institute of Oncolgy
Official's Role
Principal Investigator
Facility Information:
Facility Name
European Institute of Oncology
City
Milan
Country
Italy
Facility Name
S. Gerardo Hospital
City
Monza
ZIP/Postal Code
20052
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22621779
Citation
Biffi R, Fattori L, Bertani E, Radice D, Rotmensz N, Misitano P, Cenciarelli S, Chiappa A, Tadini L, Mancini M, Pesenti G, Andreoni B, Nespoli A. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver. World J Surg Oncol. 2012 May 23;10:94. doi: 10.1186/1477-7819-10-94.
Results Reference
derived
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Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery
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