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

Colorectal Cancer Clinical Trial

— AM  

Official title:

Surgical Sites Infections Following Colorectal Cancer Surgery. A Randomized Prospective Trial Comparing Standard and Advanced Antimicrobial Dressing Containing Ionic Silver.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981110
• Other study ID #: IEO S402/208
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2009
• Last updated: September 10, 2012
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2012
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan
Italy	S. Gerardo Hospital	Monza

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of patients with a Surgical site infection		30 days after surgery	Yes