NCT00981110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at below P25 for phase_3 colorectal-cancer

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_3 colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

August 31, 2009

Last Update Submit

September 10, 2012

Conditions

Colorectal Cancer

Keywords

Surgical site infections (SSI)Advanced antimicrobial dressing and clean surgeryHydrofibre dressing

Outcome Measures

Primary Outcomes (1)

  • The rate of patients with a Surgical site infection

    30 days after surgery

Study Arms (2)

Mepore Self-adhesive absorbent dressing

ACTIVE COMPARATOR

Mepore Self-adhesive absorbent dressing

Device: Mepore Self-adhesive absorbent dressing

AQUAGEL Ag Hydrofiber Wound Dressing

EXPERIMENTAL

AQUAGEL Ag Hydrofiber Wound Dressing

Device: AQUAGEL Ag Hydrofiber Wound Dressing

Interventions

AQUAGEL Ag Hydrofiber Wound DressingDEVICE

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

Also known as: AQUAGEL Ag Hydrofiber Wound Dressing (ConvaTee,US)
AQUAGEL Ag Hydrofiber Wound Dressing
Mepore Self-adhesive absorbent dressingDEVICE

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

Mepore Self-adhesive absorbent dressing

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

S. Gerardo Hospital

Monza, Monza, 20052, Italy

Location

European Institute of Oncology

Milan, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22621779DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsSurgical Wound Infection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bruno Andreoni, MD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

  • Roberto Biffi, MD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

  • Emilio Bertani, MD

    European Institute of Oncolgy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 22, 2009

Study Start

June 1, 2008

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

IT(2)