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

NCT ID: NCT01700504

Last Updated: 2012-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-09-30

Brief Summary

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

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).

Conditions

Axillary Drainage Volume After Lymph Node Dissection.

Keywords

Axillary drainage volume; Lavage with gentamicin solution

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Gentamicin lavage

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

Group Type: EXPERIMENTAL

Axillary lavage with gentamicin solution

Intervention Type: DRUG

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

Normal saline lavage

Patients undergoing 2 axillary lavages with 500ml of normal saline

Group Type: ACTIVE_COMPARATOR

Axillary lavage with gentamicin solution

Intervention Type: DRUG

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

Interventions

Axillary lavage with gentamicin solution

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital General Universitario Elche

OTHER

Sponsor Role: lead

Responsible Party

Jaime Ruiz-Tovar, MD, PhD

Associate Professor Universidad Miguel Hernandez

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital General de Elche

Elche, Alicante, Spain

Countries

Spain

References

Ruiz-Tovar J, Cansado P, Perez-Soler M, Gomez MA, Llavero C, Calero P, Zubiaga L, Diez M, Arroyo A, Calpena R. Effect of gentamicin lavage of the axillary surgical bed after lymph node dissection on drainage discharge volume. Breast. 2013 Oct;22(5):874-8. doi: 10.1016/j.breast.2013.03.008. Epub 2013 Apr 18.

Reference Type: DERIVED

PMID: 23602424 (View on PubMed)

Other Identifiers

2012/0009

Identifier Type: -

Identifier Source: org_study_id