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Completed

NCT Number: NCT02314806

Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irrigation with gentamicin solution

Drug

The surgical bed is irrigated with a gentamicin solution

Other names: Irrigation of the surgical bed with gentamicin solution

Irrigation with Clindamycin solution

Drug

The surgical bed is irrigated with a clindamycin solution

Other names: Irrigation of the surgical bed with Clindamycin solution

Irrigation with Normal saline

Drug

The surgical bed is irrigated with normal saline

Other names: Irrigation of the surgical bed with normal saline

Primary outcomes

  1. Drainage volume discharge

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2014
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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