Effect of Gentamicin Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume
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ClinicalTrials.gov Identifier: NCT01700504 |
Recruitment Status
:
Completed
First Posted
: October 4, 2012
Last Update Posted
: October 4, 2012
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Tracking Information | |||
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First Submitted Date ICMJE | September 24, 2012 | ||
First Posted Date ICMJE | October 4, 2012 | ||
Last Update Posted Date | October 4, 2012 | ||
Study Start Date ICMJE | May 2011 | ||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Drainage volume [ Time Frame: 7 days ] The drainage volumen between groups (interventional and control)will be analyzed.
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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 Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Effect of Gentamicin Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume | ||
Official Title ICMJE | Not Provided | ||
Brief Summary | The effect of axillary lavage with a gentamicin solution before wound closure will reduce the drainage volume and subsequently day of drainage removal. | ||
Detailed Description | 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). |
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Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Axillary Drainage Volume After Lymph Node Dissection. | ||
Intervention ICMJE | Drug: Axillary lavage with gentamicin solution
Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution |
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Study Arms |
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Publications * | 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. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
40 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date | September 2012 | ||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years to 90 Years (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Spain | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01700504 | ||
Other Study ID Numbers ICMJE | 2012/0009 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | 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 | Not Provided | ||
PRS Account | Hospital General Universitario Elche | ||
Verification Date | September 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |