Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01700504 |
| Other study ID # |
2012/0009 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
September 24, 2012 |
| Last updated |
October 2, 2012 |
| Start date |
May 2011 |
| Est. completion date |
September 2012 |
Study information
| Verified date |
September 2012 |
| Source |
Hospital General Universitario Elche |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Food and Drug AdministrationSpain: Comité Ético de Investigación Clínica |
| Study type |
Interventional
|
Clinical Trial Summary
The effect of axillary lavage with a gentamicin solution before wound closure will reduce
the drainage volume and subsequently day of drainage removal.
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).
