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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
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Brief 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

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

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

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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
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




Primary Outcome Measures :
  1. 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
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Principal Investigator: Jaime Ruiz-Tovar, MD, PhD Hospital General de Elche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Medicine Doctor, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT02314806     History of Changes
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

Additional relevant MeSH terms:
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Pharmaceutical Solutions
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action