Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314806
• Other study ID #: HGUE 2014-12
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2014
• Last updated: December 9, 2014
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The patients undergoing axillary lymph node dissection were randomized into 3 groups: patients undergoing lavages with normal saline (Group 1), patients undergoing lavage gentamicin solution (Group 2) and patients undergoing lavage with a clindamycin solution (Group 3). Drainage volume discharge is investigated

Description:

The patients undergoing axillary lymph node dissection were randomized into 3 groups: patients undergoing 2 lavages with 500 ml normal saline (Group 1), patients first undergoing lavage with 500 ml normal saline followed by a second lavage with a 500 ml of a gentamicin (240 mg) solution (Group 2) and patients first undergoing lavage with 500 ml normal saline followed by a second lavage with 500ml of a clindamycin (600mg) solution (Group 3). Drainage volume discharge is investigated

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis of breast neoplasms

• 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:

• allergy to any of the antibiotic drugs used

• chronic renal failure due to possible toxicity of gentamicin

• patients undergoing a modified radical mastectomy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Irrigation with gentamicin solution
The surgical bed is irrigated with a gentamicin solution
• Irrigation with Clindamycin solution
The surgical bed is irrigated with a clindamycin solution
• Irrigation with Normal saline
The surgical bed is irrigated with normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drainage volume discharge		14 days	Yes