Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Effect of Gentamicin Versus Clindamycin Versus Normal Saline Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Irrigation with gentamicin solution
* Drug: Irrigation with Clindamycin solution
* Drug: Irrigation with Normal saline


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irrigation with Gentamicin solution<br>The surgical bed is irrigated with a gentamicin solution | Drug: Irrigation with gentamicin solution<br>* The surgical bed is irrigated with a gentamicin solution<br>* Other names: Irrigation of the surgical bed with gentamicin solution;|
| Experimental: Irrigation with Clindamycin solution<br>The surgical bed is irrigated with a clindamycin solution | Drug: Irrigation with Clindamycin solution<br>* The surgical bed is irrigated with a clindamycin solution<br>* Other names: Irrigation of the surgical bed with Clindamycin solution;|
| Placebo Comparator: Irrigation with Normal saline<br>The surgical bed is irrigated with normal saline | Drug: Irrigation with Normal saline<br>* The surgical bed is irrigated with normal saline<br>* Other names: Irrigation of the surgical bed with normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drainage volume discharge |  | 14 days |