Clinical Trials Register

Summary
EudraCT Number:	2012-002460-27
Sponsor's Protocol Code Number:	1.1
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-09-12
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2012-002460-27

A.3

Full title of the trial

Preoperative skin preparation to lower surgical site infection in breast cancer surgery: Povidone – iodine 10% aqueous solution versus 2%chlorhexidine in 70% isopropyl alcohol (ChloraPrep, Cardinal Health). A randomized, blinded single-centre study

Studio monocentrico, randomizzato, in cieco, volto a valutare l'incidenza di infezioni della ferita in chirurgia senologica dopo preparazione della cute con clorexidina 2% in alcool 70% (CHLORAPREP) versus iodio povidone 10%

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

The study investigates the potential advantage of pre operative skin preparation with chlorhexidine-alcohol (Chloraprep)in preventing post operative surgical site infection.

Studio per valutare se la preparazione preoperatoria della cute con clorexidina-alcool � pi� efficace nella prevenzione dell'infezione di ferite rispetto a quanto � attualmente in uso (iodio povidone). Lo studio indaga specificamente gli interventi di chirurgia ''pulita'' (chirurgia senologica).

A.3.2

Name or abbreviated title of the trial where available

Povidone – iodine versus chlorhexidine alcohol

A.4.1

Sponsor's protocol code number

1.1

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ISTITUTO NAZIONALE PER LA CURA TUMORI
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Carefusion
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione IRCCS Istituto Nazionale dei Tumori
B.5.2	Functional name of contact point	Ufficio Studi Clinici
B.5.3	Address:
B.5.3.1	Street Address	Via Venezian 1
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	02 23903824
B.5.5	Fax number	02 23903991
B.5.6	E-mail	trialcenter@istitutotumori.mi.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	CHLORAPREP C/COL.*1F 26ML 1APP
D.2.1.1.2	Name of the Marketing Authorisation holder	CAREFUSION UK 244 LTD
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Cutaneous solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CHLORHEXIDINE
D.3.9.1	CAS number	55-56-1
D.3.9.4	EV Substance Code	SUB06181MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ISOPROPYL ALCOHOL
D.3.9.1	CAS number	67-63-0
D.3.9.4	EV Substance Code	SUB12085MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	70
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	DISINFETTANTE

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

PATIENTS SCHEDULED FOR SURGERY

PAZIENTI DA SOTTOPORRE AD INTERVENTO CHIRURGICO

E.1.1.1

Medical condition in easily understood language

PATIENTS UNDERGOING BREAST SURGERY FOR POSSIBLE CANCER

PAZIENTI DA OPERARE PER UN POSSIBILE TUMORE AL SENO

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	SOC
E.1.2	Classification code	10042613
E.1.2	Term	Surgical and medical procedures
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	SOC
E.1.2	Classification code	10021881
E.1.2	Term	Infections and infestations
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

REDUCTION OF POST OPERATIVE INFECTIONS

RIDURRE LE INFEZIONI POST OPERATORIE

E.2.2

Secondary objectives of the trial

TO ESTABLISH RISK FACTORS FOR INFECTYIONS AFTER BREAST SURGERY, PHARMACOECONOMICAL ANALYSIS IN CASE OF SUPERIORITY OF ONE OUT OF THE TWO TREATMENTS

STABILIRE I FATTORI DI RISCHIO DELL'INFEZIONE DOPO CHIRURGIA AL SENO, VALUTAZIONE FARMACOECONOMICA IN CASO DI SUPERIORITA' DI UN TRATTAMENTO

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

PHARMACOECONOMIC:
Vers:1.1
Date:2012/04/05
Title:Preoperative skin preparation to lower surgical site infection in breast cancer surgery: Povidone – iodine 10% aqueous solution versus 2%chlorhexidine in 70% isopropyl alcohol (ChloraPrep, Cardinal Health).
A randomized, blinded single-centre study
Objectives:ANALYSIS OF COST EFFECTIVENESS IN CASE OF SUPERIORITY IN PREVENTING POST OPERATIVE INFECTION

FARMACOECONOMIA:
Vers:1.1
Data:2012/04/05
Titolo:STUDIO MONOCENTRICO, RANDOMIZZATO, IN CIECO, VOLTO A VALUTARE L'INCIDENZA DI INFEZIONI DELLA FERITA IN CHIRURGIA SENOLOGICA DOPO PREPARAZIONE PREOPERATORIA DELLA CUTE CON CLOREXIDINA 2% IN ALCOOL 70% (CHLORAPREP) VERSUS IODIO POVIDONE 10%
Obiettivi:VALUTARE IL COSTO/BENEFICIO DEL TRATTAMENTO QUALORA UNO DEI DUE BRACCI RISULTASSE SUPERIORE

E.3

Principal inclusion criteria

PATIENTS SCHEDULED FOR BREAST SURGERY IN ISTITUTO NAZIONALE DEI TUMORI

PAZIENTI DA OPERARE PRESSO ISTITUTO NAZIONALE DEI TUMORI

E.4

Principal exclusion criteria

PATIENT REFUSAL, INFECTION IN ANY SITE BEFORE SURGERY, pregnancy

RIFIUTO DELLA PAZIENTE, INFEZIONE IN ATTO, stato di gravidanza

E.5 End points

E.5.1

Primary end point(s)

REDUCTION OF THE SURGICAL SITE INFECTION

RIDUZIONE DELL'INCIDENZA DI INFEZIONE DELLA FERITA CHIRURGICA

E.5.1.1

Timepoint(s) of evaluation of this end point

1 MONTH, 6 MONTHS

1 MESE SENZA PROTESI E 6 MESI CON PROTESI

E.5.2

Secondary end point(s)

RISK FACTORS ANALYSIS FOR POST OPERATIVE INFECTIONS

ANALISI FATTORI DI RISCHIO

E.5.2.1

Timepoint(s) of evaluation of this end point

1 MONTH, 6 MONTHS

1 MESE SENZA PROTESI E 6 MESI CON PROTESI

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

RISK FACTORS

FATTORI DI RISCHIO

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

IODIO POVIDONE 10% SOLUZIONE ACQUOSA

POVIDONE IODINE 10% ACQUEOUS SOLUTION

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

1500

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

680

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-09-12.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

2160

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

STANDARD INSTITUTIONAL TREATMENT

NORMALI PROTOCOLLI CLINICI

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-02-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-07-17

P. End of Trial
P.	End of Trial Status	Completed

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