AzTrials
AzTrials

Wound InfectionPhase 4NCT02479347

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

A Phase 4 study testing Chlorhexidine and Povidone-Iodine in people with Wound Infection and Breast Neoplasms, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Wound Infection, Breast Neoplasms
What is being tested?
Chlorhexidine and Povidone-Iodine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,158 participants
Where
1 siteItaly
Study dates
Mar 2013to Sep 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Mi, 20133

Other trials in Italy

About this study

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

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.

Read the 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).
Being tested
Chlorhexidine, Povidone-Iodine
Keywords
General surgery, Postoperative
Medical subject headings
Wound Infection, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChlorhexidineDrug

    Also called Chloraprep (Carefusion)

    Preoperative skin preparation with tinted chlorhexidine gluconate 2% in 70% isopropyl alcohol administered with single-dose applicator

  • Povidone-IodineDrug

    Also called Betadine

    Preoperative skin preparation with povidone-iodine 10% aqueous solution

Study groups in NCT02479347
Study groupRoleWhat they receive
ChloraprepExperimentalPreoperative skin preparation with chlorhexidine 2% in alcohol 70% solution
Receives: Drug: Chlorhexidine
Povidone-iodineActive comparatorPreoperative skin preparation with povidone-iodine 10% solution
Receives: Drug: Povidone-Iodine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of wound infection after surgery (composite outcome)

    Overall incidence of surgical site infections after surgery

    Measured: 30 days after surgery without breast implant and 180 days after surgery with implant

Secondary outcomes (4)

  1. Incidence of deep surgical site infection after surgery without implant

    Overall incidence of surgical site infections after surgery without implant

    Measured: 30 days after surgery

  2. Incidence of deep surgical site infection after surgery with implant

    Overall incidence of surgical site infections after surgery with implant

    Measured: 180 days after surgery

  3. Risk factors for surgical site infection evaluation

    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

    Measured: 30 and 180 days after surgery

  4. Analysis of extra-cost indicators

    Record of number of additional hospital admission due to wound infection; Length of hospital stay; Need for additional surgery due to wound infection;Days of additional antibiotic therapy due to wound infection

    Measured: 180 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2015 (estimated)
  2. Study startMar 2013
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
2,158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02479347
Sponsor's protocol ID
INT-81/12
Other IDs
2012-002460-27
Status last verified
Sep 2021
First submitted
15 Jun 2015
Last updated
9 Sep 2021
Results posted
No
Data monitoring committee
No

Publications

  • Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.

    PubMed 10219875

  • Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.

    PubMed 20054046

  • Lee I, Agarwal RK, Lee BY, Fishman NO, Umscheid CA. Systematic review and cost analysis comparing use of chlorhexidine with use of iodine for preoperative skin antisepsis to prevent surgical site infection. Infect Control Hosp Epidemiol. 2010 Dec;31(12):1219-29. doi: 10.1086/657134. Epub 2010 Oct 22.

    PubMed 20969449

  • Noorani A, Rabey N, Walsh SR, Davies RJ. Systematic review and meta-analysis of preoperative antisepsis with chlorhexidine versus povidone-iodine in clean-contaminated surgery. Br J Surg. 2010 Nov;97(11):1614-20. doi: 10.1002/bjs.7214.

    PubMed 20878942

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Chlorhexidine and Povidone-Iodine in people with Wound Infection and Breast Neoplasms, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of wound infection after surgery (composite outcome) (time frame: 30 days after surgery without breast implant and 180 days after surgery with implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02479347, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in