Status:
COMPLETED
Use of Clorhexidine Dressings to Reduce Surgical Site Infections in Breast Cancer Surgery. A Controlled Clinical Trial
Lead Sponsor:
National Institute of Cancerología
Collaborating Sponsors:
Instituto Nacional de Rehabilitacion
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of sick woman could delay the adjuvant therapy and ...
Detailed Description
Following approval by the National Cancer Institute Review Board, eligible subjects will be recruited prospectively from the Breast Cancer Department at National Cancer Institute, México from November...
Eligibility Criteria
Inclusion
- Females minimum age 18 able to give informed consent
- Breast cancer confirmed by histopathology
- Patients undergoing unilateral or bilateral mastectomy with or without immediate expander reconstruction.
Exclusion
- Males
- Patients who deny informed consent
- Prior radiation therapy to the sick breast.
- Pregnant or breastfeeding women
- Patients undergoing immediate breast reconstruction with Deep Inferior
- Epigastric Perforator (DIEP) o Transverse Rectus Abdominal Muscle techniques (TRAM) .
- Emergency procedures
- Documented allergy to chlorhexidine gluconate
- Antibiotic use in the fourteen days prior to surgical date
- Patients with a history or suspicion of breast cancer surgery outside the INCan in the previous three months.
- Patients who do not speak spanish, diagnosed with a psychiatric disorder and in whom a minimum follow-up of 14 days couldn't be feasible because of operative difficulties (eg.
- place of residence or reference to other health institutions).
Key Trial Info
Start Date :
October 3 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2018
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03229824
Start Date
October 3 2016
End Date
May 30 2018
Last Update
November 13 2018
Active Locations (1)
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1
Instituto Nacional de Cancerología
Mexico City, Mexico City, Mexico, 14080