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

NCT ID: NCT00981110

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Colorectal Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mepore Self-adhesive absorbent dressing

Mepore Self-adhesive absorbent dressing

Group Type ACTIVE_COMPARATOR

Mepore Self-adhesive absorbent dressing

Intervention Type DEVICE

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

AQUAGEL Ag Hydrofiber Wound Dressing

AQUAGEL Ag Hydrofiber Wound Dressing

Group Type EXPERIMENTAL

AQUAGEL Ag Hydrofiber Wound Dressing

Intervention Type DEVICE

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

Interventions

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AQUAGEL Ag Hydrofiber Wound Dressing

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

Intervention Type DEVICE

Mepore Self-adhesive absorbent dressing

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

Intervention Type DEVICE

Other Intervention Names

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AQUAGEL Ag Hydrofiber Wound Dressing (ConvaTee,US)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruno Andreoni, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Roberto Biffi, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Emilio Bertani, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncolgy

Locations

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S. Gerardo Hospital

Monza, Monza, Italy

Site Status

European Institute of Oncology

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 22621779 (View on PubMed)

Other Identifiers

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IEO S402/208

Identifier Type: -

Identifier Source: org_study_id