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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00981110

Acronym

Enrollment

120

Registered

2009-09-22

Start date

2008-06-30

Completion date

2010-12-31

Last updated

2012-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Surgical site infections (SSI), Advanced antimicrobial dressing and clean surgery, Hydrofibre dressing

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.

Interventions

DEVICEAQUAGEL Ag Hydrofiber Wound Dressing

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

DEVICEMepore Self-adhesive absorbent dressing

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The rate of patients with a Surgical site infection	30 days after surgery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026