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

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 - Povidone – iodine versus chlorhexidine alcohol

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002460-27-IT

Enrollment

Unknown

Registered

2012-09-12

Start date

2013-02-04

Completion date

Unknown

Last updated

2017-04-03

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

Conditions

PATIENTS SCHEDULED FOR SURGERY MedDRA version: 15.0 Level: SOC Classification code 10042613 Term: Surgical and medical procedures System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 15.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: CHLORAPREP C/COL.*1F 26ML 1APP Pharmaceutical Form: Cutaneous solution INN or Proposed INN: CHLORHEXIDINE CAS Number: 55-56-1 Concentration unit: % percent Concentration type: equal Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: PATIENTS SCHEDULED FOR BREAST SURGERY IN ISTITUTO NAZIONALE DEI TUMORI Are the trial subjects under 18? no Number of subjects for this age range: 0 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

Exclusion criteria

Exclusion criteria: PATIENT REFUSAL, INFECTION IN ANY SITE BEFORE SURGERY, pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: REDUCTION OF POST OPERATIVE INFECTIONS;Secondary Objective: TO ESTABLISH RISK FACTORS FOR INFECTYIONS AFTER BREAST SURGERY, PHARMACOECONOMICAL ANALYSIS IN CASE OF SUPERIORITY OF ONE OUT OF THE TWO TREATMENTS;Primary end point(s): REDUCTION OF THE SURGICAL SITE INFECTION;Timepoint(s) of evaluation of this end point: 1 MONTH, 6 MONTHS	—

Secondary

Measure	Time frame
Secondary end point(s): RISK FACTORS ANALYSIS FOR POST OPERATIVE INFECTIONS;Timepoint(s) of evaluation of this end point: 1 MONTH, 6 MONTHS	—

Countries

Italy

Contacts

Public ContactUfficio Studi Clinici

Fondazione IRCCS Istituto Nazionale dei Tumori

trialcenter@istitutotumori.mi.it02 23903824

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026