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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700504
First Posted: October 4, 2012
Last Update Posted: October 4, 2012
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.
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
September 24, 2012
October 4, 2012
October 4, 2012
May 2011
September 2012   (Final data collection date for primary outcome measure)
Drainage volume [ Time Frame: 7 days ]
The drainage volumen between groups (interventional and control)will be analyzed.
Same as current
No Changes Posted
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Effect of Gentamicin Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume
Not Provided
The effect of axillary lavage with a gentamicin solution before wound closure will reduce the drainage volume and subsequently day of drainage removal.

Inclusion criteria will be a diagnosis of mammary neoplasms and 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 will be chronic renal failure due to possible toxicity of gentamicin and patients undergoing a modified radical mastectomy.

The patients will be randomized by means of an Internet randomization module into 2 groups: those patients undergoing 2 lavages of the axillary surgical bed with normal saline (Group 1) and those ones first undergoing lavage with normal saline followed by a second lavage with a gentamicin solution (Group 2).

Surgical dissection will be performed using harmonic scalpel (Ultracision, Ethicon Endosurgery, Johnson and Johnson, Cincinnati, OH, USA). Once finished the ALND, a Jackson-Pratt drain will be left in place and connected to a low pressure vacuum device.

Methodology: Irrigation technique and extraction of microbiological samples:

The lavage will be performed immediately prior to closure of the wound, once placed the drainage into the cavity. In both groups, prior to the lavage, a microbiological sample from the surgical bed will be obtained with a swab (sample 1), followed by a lavage with 500 ml normal saline. After aspiration of the saline, a new microbiological sample will be obtained (sample 2). In Group 1 a second lavage with 500 ml normal saline will be performed, while in Group 2 the second lavage will be performed with an antibiotic solution, including gentamicin (240 mg) dissolved in 500 ml normal saline. After aspirating this second lavage, a third microbiological sample will be obtained in the same way as the two previous ones, in both groups (sample 3).

Indication of drain removal and obtention of sample 4:

After discharge, the patient will be asked to quantify the drainage volume daily. Drain will be removed when drainage volume was <30 ml/day. The drainage volume of the last day was collected in a syringe for microbiological study (sample 4).

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Axillary Drainage Volume After Lymph Node Dissection.
Drug: Axillary lavage with gentamicin solution
Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution
  • Experimental: Gentamicin lavage
    Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution
    Intervention: Drug: Axillary lavage with gentamicin solution
  • Active Comparator: Normal saline lavage
    Patients undergoing 2 axillary lavages with 500ml of normal saline
    Intervention: Drug: Axillary lavage with gentamicin solution
Ruiz-Tovar J, Cansado P, Perez-Soler M, Gomez MA, Llavero C, Calero P, Zubiaga L, Diez M, Arroyo A, Calpena R. Effect of gentamicin lavage of the axillary surgical bed after lymph node dissection on drainage discharge volume. Breast. 2013 Oct;22(5):874-8. doi: 10.1016/j.breast.2013.03.008. Epub 2013 Apr 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of mammary neoplasms and 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:

  • chronic renal failure due to possible toxicity of gentamicin
  • patients undergoing a modified radical mastectomy.
Sexes Eligible for Study: Female
20 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01700504
2012/0009
Not Provided
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Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
Hospital General Universitario Elche
Not Provided
Not Provided
Hospital General Universitario Elche
September 2012

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