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

NCT02479347 | Completed Phase 4

• 2 other identifiers: INT-81/122012-002460-27
• Study Type: interventional
• Target: 2,158
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Infection; Breast Neoplasms

Keywords

General surgery; Postoperative

Outcome Measures

Primary Outcomes (1)

• Incidence of wound infection after surgery (composite outcome)

  Overall incidence of surgical site infections after surgery

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

Secondary Outcomes (4)

• Incidence of deep surgical site infection after surgery without implant

  30 days after surgery

• Incidence of deep surgical site infection after surgery with implant

  180 days after surgery

• Risk factors for surgical site infection evaluation

  30 and 180 days after surgery

• Analysis of extra-cost indicators

  180 days after surgery

Other Outcomes (1)

• Cost-effective analysis

  180 days after surgery

Study Arms (2)

Chloraprep

EXPERIMENTAL

Preoperative skin preparation with chlorhexidine 2% in alcohol 70% solution

Drug: Chlorhexidine

Povidone-iodine

ACTIVE COMPARATOR

Preoperative skin preparation with povidone-iodine 10% solution

Drug: Povidone-Iodine

Interventions

Chlorhexidine DRUG

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

Also known as: Chloraprep (Carefusion)

Chloraprep

Povidone-Iodine DRUG

Preoperative skin preparation with povidone-iodine 10% aqueous solution

Also known as: Betadine

Povidone-iodine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Mi, 20133, Italy

Location

Related Publications (4)

• 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.

  PMID: 10219875 BACKGROUND

• 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.

  PMID: 20054046 BACKGROUND

• 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.

  PMID: 20969449 BACKGROUND

• 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.

  PMID: 20878942 BACKGROUND

MeSH Terms

Conditions

Wound Infection; Breast Neoplasms

Interventions

Chlorhexidine; Povidone-Iodine

Condition Hierarchy (Ancestors)

Infections; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Martin Langer, Prof

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 24, 2015
• Study Start: March 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

IT (1)