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OpenTrials
Completed

NCT Number: NCT01700504

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

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

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Key information

Age range

20 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital General de Elche

Elche, Alicante, 03203, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Axillary lavage with gentamicin solution

Drug

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

Primary outcomes

  1. Drainage volume

    Time frame: 7 days

    The drainage volumen between groups (interventional and control)will be analyzed.

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2012
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.