Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT01286168
Eligibility Criteria:
Inclusion Criteria:
* Females or males age 18-90 able to give informed consent
* Undergoing bilateral mastectomy with immediate expander reconstruction or immediate implant reconstruction
* May have either malignant or benign breast condition
Exclusion Criteria:
* Antibiotic use in the fourteen days prior to surgical date
* Undergoing unilateral tissue expander reconstruction
* Documented allergy to chlorhexidine gluconate
* Prior radiation therapy to the breast or chest wall (ie for breast conservation or mantle radiation for Hodgkin's disease)
* Documented allergy to all three of the following antibiotics: cephalosporin, trimethoprim/sulfamethoxazole, and levofloxacin
* Pregnant women
* Vulnerable subjects - prisoners, institutionalized individuals
* Non-English speaking patients without adequate interpreter assistance
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01286168
Study Brief:
Protocol Section:
NCT01286168