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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Infections Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Surgical Wound Infection Wound Infection

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

S. Gerardo Hospital, Monza, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AQUAGEL Ag Hydrofiber Wound Dressing

Device

Hydrofibre dressing containing ionic silver: medication performed as for frequency and duration according standard procedure

Other names: AQUAGEL Ag Hydrofiber Wound Dressing (ConvaTee,US)

Mepore Self-adhesive absorbent dressing

Device

Standard dressing: medication performed as for frequency and duration according standard procedure

Primary outcomes

The rate of patients with a Surgical site infection

Time frame: 30 days after surgery

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Acronym: AM

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Sep 22, 2009
Registry last updated: Sep 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed