Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Irrigation with Clindamycin solution; Drug: Irrigation with Normal saline; Drug: Irrigation with gentamicin solution

• Registration Number: NCT02314806
• Lead Sponsor: Hospital General Universitario Elche

Brief 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

Detailed 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

Study Timeline

• Study Start: 2013-01
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2014-12-07
• Study First Submitted QC: 2014-12-09
• Last Update Submitted: 2014-12-09
• Study First Posted: 2014-12-11
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irrigation with Clindamycin solution	Irrigation with Clindamycin solution	The surgical bed is irrigated with a clindamycin solution
Irrigation with Normal saline	Irrigation with Normal saline	The surgical bed is irrigated with normal saline
Irrigation with Gentamicin solution	Irrigation with gentamicin solution	The surgical bed is irrigated with a gentamicin solution

Primary Outcome Measures

Name	Time	Method
Drainage volume discharge	14 days