Breast Cancer Clinical Trial
Official title:
Randomized Controlled Trial to Reduce Surgical Site Infections in Breast Cancer Surgery With Clorhexidine Gluconate Securement Dressing (Tegaderm CHG)
Verified date | November 2018 |
Source | National Institute of Cancerología |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 result increase morbidity and mortality. Also this increased costs associated with health care.Surgical drains have been noted as a potential source for surgical site infections. The primary aim of the study is to determine if chlorhexidine occlusive dressings applied to the intervention drain sites effectively decreases rates of bacterial colonization in drain fluid and drain tips compared to standard care.
Status | Completed |
Enrollment | 116 |
Est. completion date | May 30, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Cancerología | Mexico City | DF |
Lead Sponsor | Collaborator |
---|---|
National Institute of Cancerología | Instituto Nacional de Rehabilitacion |
Mexico,
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XXXIII Congreso Nacional de la Asociación Mexicana de Infectología y Microbiología Clínica, A.C. León, Guanajuato; 14-17 de mayo de 2008.
* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects with drain bulb fluid bacterial colonization at the first and second week postoperative. | Bacterial growth was defined as plate growth >10*5 colony forming unit (CFU). Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture. | Approximately 1 or 2 weeks after surgery | |
Primary | Number of subjects with drain tip bacterial colonization at removal. | Bacterial growth was defined as plate growth >15 CFU by semiquantitative technique or >10*5 CFU by sonication and fluid culture. Drains were removed at variable times across patients, per clinical indication. | Approximately at the second and/or third week after surgery | |
Secondary | Number of Subjects With Surgical Site Infection Within 30 Days | Surgical site infection was diagnosed according the definitions given by the Centers for Disease Control and Prevention (CDC). | Approximately 30 days after surgery |
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