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

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Device: Mepore Self-adhesive absorbent dressing; Device: AQUAGEL Ag Hydrofiber Wound Dressing

• Registration Number: NCT00981110
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2010-10
• Study Completion: 2010-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-10
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepore Self-adhesive absorbent dressing	Mepore Self-adhesive absorbent dressing	Mepore Self-adhesive absorbent dressing
AQUAGEL Ag Hydrofiber Wound Dressing	AQUAGEL Ag Hydrofiber Wound Dressing	AQUAGEL Ag Hydrofiber Wound Dressing

Primary Outcome Measures

Name	Time	Method
The rate of patients with a Surgical site infection	30 days after surgery

Trial Locations

Locations (2)

S. Gerardo Hospital; 🇮🇹 Monza, Italy

European Institute of Oncology; 🇮🇹 Milan, Italy