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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
ClinicalTrials.gov Identifier:
NCT01700504
First received: September 24, 2012
Last updated: October 2, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Axillary Drainage Volume After Lymph Node Dissection.
Drug: Axillary lavage with gentamicin solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Hospital General Universitario Elche:

Primary Outcome Measures:
  • Drainage volume [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    The drainage volumen between groups (interventional and control)will be analyzed.


Enrollment: 40
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gentamicin lavage
Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution
Drug: Axillary lavage with gentamicin solution
Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution
Active Comparator: Normal saline lavage
Patients undergoing 2 axillary lavages with 500ml of normal saline
Drug: Axillary lavage with gentamicin solution
Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution

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

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700504

Locations
Spain
Hospital General de Elche
Elche, Alicante, Spain, 03203
Sponsors and Collaborators
Hospital General Universitario Elche
  More Information

No publications provided by Hospital General Universitario Elche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Associate Professor Universidad Miguel Hernandez, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT01700504     History of Changes
Other Study ID Numbers: 2012/0009
Study First Received: September 24, 2012
Last Updated: October 2, 2012
Health Authority: United States: Food and Drug Administration
Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital General Universitario Elche:
Axillary drainage volume
Lavage with gentamicin solution

Additional relevant MeSH terms:
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014