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

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Axillary Drainage Volume After Lymph Node Dissection.

Treatments: Drug: Axillary lavage with gentamicin solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01700504

2012/0009

Details and patient eligibility

About

The effect of axillary lavage with a gentamicin solution before wound closure will reduce the drainage volume and subsequently day of drainage removal.

Full 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).

Enrollment: 40 patients

Sex: Female

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Gentamicin lavage

Experimental group

Description:

Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution

Treatment:

Drug: Axillary lavage with gentamicin solution

Normal saline lavage

Active Comparator group

Description:

Patients undergoing 2 axillary lavages with 500ml of normal saline

Treatment:

Drug: Axillary lavage with gentamicin solution