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Wound Infections in Breast Cancer Surgery After Preoperative Skin Preparation With Chlorhexidine vs. Povidone-iodine

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ClinicalTrials.gov Identifier: NCT02479347
Recruitment Status : Unknown
Verified June 2015 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
First Posted : June 24, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:
The development of surgical site infections (SSI) in clean-contaminated surgery is regarded as being preventable. Known to be effective in the prevention of surgical site infection are the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic prophylaxis where indicated, and certainly the preparation of the skin at the incision site, since the patient's skin is the principal source of bacterial contamination of the wound. This study aims to investigate the efficacy in prevention of surgical site infection in clean surgery, using two different standardized methods of skin preparation: povidone-iodine 10% aqueous solution from 1.5 liter bulk bottle, versus tinted 2% chlorhexidine in 70% isopropyl alcohol in a single-dose applicator. To reduce the variables involved, a single-center study will enroll a homogeneous population, undergoing breast cancer surgery.

Condition or disease Intervention/treatment Phase
Wound Infection Breast Neoplasms Drug: Chlorhexidine Drug: Povidone-Iodine Phase 4

Detailed Description:

The development of surgical site infections (SSI) in clean-contaminated surgery is regarded as being preventable. Known to be effective in the prevention of surgical site infection are the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic prophylaxis where indicated, and certainly the preparation of the skin at the incision site, since the patient's skin is the principal source of bacterial contamination of the wound. Products generally used for preoperative preparation of the skin are iodophores (povidone-iodine), and products containing alcohol and/or chlorhexidine.

To date, in the literature there are quite a number of case studies, but only few randomized controlled trials (RCTs) that compare different methods of preparation of the skin at the site of surgery. Only recently a major study comparing between 2 modes of skin preparation before surgery has been performed and published, and at least 2 systematic reviews of various methods can be found. At present, the use of chlorhexidine in alcohol is seen to be more effective than povidone-iodine in the prevention of surgical site infection, but the data derived from the available studies are not sufficient to definitely support a change in the daily practice, and quantitative evaluation of pharmaco-economics implications are still missing.

This study aims to investigate the efficacy in prevention of surgical site infection in clean surgery, using two different standardized methods of skin preparation: povidone-iodine 10% aqueous solution from 1.5 liter bulk bottle, versus tinted 2% chlorhexidine in 70% isopropyl alcohol in a single-dose applicator. To reduce the variables involved, a single-center study will enroll a homogeneous population, undergoing breast cancer surgery.

The patients included in this study will be randomized according to the week in which they will receive surgical treatment. The investigators expect this approach to be easier to manage within this study. The randomly assigned treatment will be weekly communicated to the chief nurse of the operating theatre who will supply the proper disinfectant without any other role in the study.

All patients will be scheduled for at least one follow up visit after about 2 weeks after surgery. All patients have access to more follow up visits, if needed, and will be asked to report all kind of wound complications.

The wound assessment will be made by persons not aware of the treatment arm the patient was assigned to, and a defined protocol assessment, based on Centers for Disease Control and prevention (CDC) definitions, which provides the following classification:

  1. absence of infection;
  2. superficial wound infection;
  3. deep wound infection. The final follow-up visit during which the patient will be evaluated will be conducted at 30 days (for patients without insertion of prosthesis / expander) and at 180 days (for patients with the insertion of implants / expander).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Blinded, Single Center Study to Assess the Incidence of Surgical Site Infections in Breast Cancer Surgery After Preoperative Skin Preparation With Chlorhexidine 2% in Alcohol 70% (CHLORAPREP ®) Versus 10% Povidone-iodine
Study Start Date : March 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: Chloraprep
Preoperative skin preparation with chlorhexidine 2% in alcohol 70% solution
Drug: Chlorhexidine
Preoperative skin preparation with tinted chlorhexidine gluconate 2% in 70% isopropyl alcohol administered with single-dose applicator
Other Name: Chloraprep (Carefusion)

Active Comparator: Povidone-iodine
Preoperative skin preparation with povidone-iodine 10% solution
Drug: Povidone-Iodine
Preoperative skin preparation with povidone-iodine 10% aqueous solution
Other Name: Betadine




Primary Outcome Measures :
  1. Incidence of wound infection after surgery without implant [ Time Frame: 30 days after surgery without breast implant ]
    Overall incidence of surgical site infections after surgery

  2. Incidence of wound infection after surgery with implant [ Time Frame: 180 days after surgery with breast implant ]
    Overall incidence of surgical site infections after surgery


Secondary Outcome Measures :
  1. Incidence of deep surgical site infection after surgery without implant [ Time Frame: 30 days after surgery ]
  2. Incidence of deep surgical site infection after surgery with implant [ Time Frame: 180 days after surgery ]
  3. Risk factors for surgical site infection evaluation [ Time Frame: 30 and 180 days after surgery ]
    Multivariate analysis of risk factors: presence or absence of implant, previous chemotherapy treatment, previous radiotherapy treatment, American Society Association class > 2, length of surgery > 2 hours, body mass index > 35, diabetes mellitus

  4. Analysis of extra-cost indicators [ Time Frame: 180 days after surgery ]
    Record of number of additional hospital admission, length of stay, need of additional surgery, days of additional antibiotic therapy, delay of anticancer therapy due to wound infection


Other Outcome Measures:
  1. Cost-effective analysis [ Time Frame: 180 days after surgery ]
    Cost-effective analysis if one treatment proves significantly superior to the other



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing breast surgery at the Fondazione IRCCS National Cancer Institute in Milan (Italy), with or without reconstructive surgery / prosthesis or expander insertion
  • Acceptance of the procedures of the protocol
  • Signature of informed consent for the study

Exclusion Criteria:

  • Refusal of the patient
  • Age < 18 years
  • Pregnancy
  • Patients undergoing abdominal DIEP flap reconstruction
  • Allergy to one of the disinfectants;
  • Pre-existing infection in any body site

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479347


Contacts
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Contact: Martin Langer, Prof +39223902282 martin.langer@istitutotumori.mi.it

Locations
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Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milan, Mi, Italy, 20133
Contact: Martin Langer, Prof    +39223902282    martin.langer@istitutotumori.mi.it   
Contact: Federico Piccioni, MD    +39223902282    federico.piccioni@istitutotumori.mi.it   
Principal Investigator: Martin Langer, Prof         
Sub-Investigator: Roberto Agresti, MD         
Sub-Investigator: Ilaria Maugeri, MD         
Sub-Investigator: Luigi Mariani, MD         
Sub-Investigator: Federico Piccioni, MD         
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Study Chair: Martin Langer, Prof Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Publications:
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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02479347     History of Changes
Other Study ID Numbers: INT-81/12
2012-002460-27 ( EudraCT Number )
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015
Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
General surgery
Postoperative
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Iodine
Chlorhexidine
Chlorhexidine gluconate
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Physiological Effects of Drugs
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Plasma Substitutes
Blood Substitutes