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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

Page last updated: August 23, 2015

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