Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla
Information source: Hospital General Universitario Elche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Irrigation with gentamicin solution (Drug); Irrigation with Clindamycin solution (Drug); Irrigation with Normal saline (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hospital General Universitario Elche Official(s) and/or principal investigator(s): Jaime Ruiz-Tovar, MD, PhD, Principal Investigator, Affiliation: Hospital General de Elche
Summary
The patients undergoing axillary lymph node dissection were randomized into 3 groups:
patients undergoing lavages with normal saline (Group 1), patients undergoing lavage
gentamicin solution (Group 2) and patients undergoing lavage with a clindamycin solution
(Group 3). Drainage volume discharge is investigated
Clinical Details
Official title: Effect of Gentamicin Versus Clindamycin Versus Normal Saline Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: Drainage volume discharge
Detailed description:
The patients undergoing axillary lymph node dissection were randomized into 3 groups:
patients undergoing 2 lavages with 500 ml normal saline (Group 1), patients first undergoing
lavage with 500 ml normal saline followed by a second lavage with a 500 ml of a gentamicin
(240 mg) solution (Group 2) and patients first undergoing lavage with 500 ml normal saline
followed by a second lavage with 500ml of a clindamycin (600mg) solution (Group 3). Drainage
volume discharge is investigated
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- diagnosis of breast neoplasms
- plans to undergo an elective ALND of Berg's levels I and II due to axillary
metastasis determined preoperatively by core biopsy or evidence of metastasis in the
SLNB in the intraoperative or in the differed analysis.
Exclusion Criteria:
- allergy to any of the antibiotic drugs used
- chronic renal failure due to possible toxicity of gentamicin
- patients undergoing a modified radical mastectomy.
Locations and Contacts
Additional Information
Starting date: January 2013
Last updated: December 9, 2014
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