Clinical trial · Interventional
Wound Infections in Breast Cancer Surgery After Preoperative Skin Preparation With Chlorhexidine vs. Povidone-iodine
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Wound Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorhexidine | Drug | — | UNRESOLVED |
| Povidone-Iodine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chloraprep
- description
- Preoperative skin preparation with chlorhexidine 2% in alcohol 70% solution
- interventionNames
- Drug: Chlorhexidine
- type
- ACTIVE_COMPARATOR
- label
- Povidone-iodine
- description
- Preoperative skin preparation with povidone-iodine 10% solution
- interventionNames
- Drug: Povidone-Iodine
Primary outcomes (1)
- measure
- Incidence of wound infection after surgery (composite outcome)
- timeFrame
- 30 days after surgery without breast implant and 180 days after surgery with implant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDMangram 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
- BACKGROUNDDarouiche 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
- BACKGROUNDLee 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
- BACKGROUNDNoorani 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