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Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 7, 2014
First Posted Date  ICMJE December 11, 2014
Last Update Posted Date December 11, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
Drainage volume discharge [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla
Official Title  ICMJE Effect of Gentamicin Versus Clindamycin Versus Normal Saline Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume
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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Irrigation with gentamicin solution
    The surgical bed is irrigated with a gentamicin solution
    Other Name: Irrigation of the surgical bed with gentamicin 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
  • Drug: Irrigation with Normal saline
    The surgical bed is irrigated with normal saline
    Other Name: Irrigation of the surgical bed with normal saline
Study Arms  ICMJE
  • Experimental: Irrigation with Gentamicin solution
    The surgical bed is irrigated with a gentamicin solution
    Intervention: Drug: Irrigation with gentamicin solution
  • Experimental: Irrigation with Clindamycin solution
    The surgical bed is irrigated with a clindamycin solution
    Intervention: Drug: Irrigation with Clindamycin solution
  • Placebo Comparator: Irrigation with Normal saline
    The surgical bed is irrigated with normal saline
    Intervention: Drug: Irrigation with Normal saline
Publications * Oller I, Ruiz-Tovar J, Cansado P, Zubiaga L, Calpena R. Effect of Lavage with Gentamicin vs. Clindamycin vs. Physiologic Saline on Drainage Discharge of the Axillary Surgical Bed after Lymph Node Dissection. Surg Infect (Larchmt). 2015 Dec;16(6):781-4. doi: 10.1089/sur.2015.020. Epub 2015 Aug 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2014)
51
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02314806
Other Study ID Numbers  ICMJE HGUE 2014-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
Study Sponsor  ICMJE Hospital General Universitario Elche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jaime Ruiz-Tovar, MD, PhD Hospital General de Elche
PRS Account Hospital General Universitario Elche
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP