Effect of Gentamicin Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume
Information source: Hospital General Universitario Elche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Axillary Drainage Volume After Lymph Node Dissection.
Intervention: Axillary lavage with gentamicin solution (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hospital General Universitario Elche
Summary
The effect of axillary lavage with a gentamicin solution before wound closure will reduce
the drainage volume and subsequently day of drainage removal.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Drainage volume
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).
Eligibility
Minimum age: 20 Years.
Maximum age: 90 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- diagnosis of mammary neoplasms and plans to undergo an elective ALND of BergĀ“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.
Locations and Contacts
Hospital General de Elche, Elche, Alicante 03203, Spain
Additional Information
Starting date: May 2011
Last updated: October 2, 2012
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