Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla
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ClinicalTrials.gov Identifier: NCT02314806 |
Recruitment Status :
Completed
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Irrigation with gentamicin solution Drug: Irrigation with Clindamycin solution Drug: Irrigation with Normal saline | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
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 Start Date : | January 2013 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Irrigation with Gentamicin solution
The surgical bed is irrigated with a gentamicin solution
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Drug: Irrigation with gentamicin solution
The surgical bed is irrigated with a gentamicin solution
Other Name: Irrigation of the surgical bed with gentamicin solution |
Experimental: Irrigation with Clindamycin solution
The surgical bed is irrigated with a clindamycin solution
|
Drug: Irrigation with Clindamycin solution
The surgical bed is irrigated with a clindamycin solution
Other Name: Irrigation of the surgical bed with Clindamycin solution |
Placebo Comparator: Irrigation with Normal saline
The surgical bed is irrigated with normal saline
|
Drug: Irrigation with Normal saline
The surgical bed is irrigated with normal saline
Other Name: Irrigation of the surgical bed with normal saline |
- Drainage volume discharge [ Time Frame: 14 days ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314806
Principal Investigator: | Jaime Ruiz-Tovar, MD, PhD | Hospital General de Elche |
Responsible Party: | Jaime Ruiz-Tovar, MD, PhD, Medicine Doctor, Hospital General Universitario Elche |
ClinicalTrials.gov Identifier: | NCT02314806 |
Other Study ID Numbers: |
HGUE 2014-12 |
First Posted: | December 11, 2014 Key Record Dates |
Last Update Posted: | December 11, 2014 |
Last Verified: | December 2014 |
Clindamycin Clindamycin palmitate Clindamycin phosphate Gentamicins Pharmaceutical Solutions |
Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |