Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Irrigation with Normal saline; Drug: Irrigation with Clindamycin solution; Drug: Irrigation with gentamicin solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02314806

HGUE 2014-12

Details and patient eligibility

About

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

Full 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

Enrollment: 51 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 3 patient groups, including a placebo group

Irrigation with Gentamicin solution

Experimental group

Description:

The surgical bed is irrigated with a gentamicin solution

Treatment:

Drug: Irrigation with gentamicin solution

Irrigation with Clindamycin solution

Experimental group

Description:

The surgical bed is irrigated with a clindamycin solution

Treatment:

Drug: Irrigation with Clindamycin solution

Irrigation with Normal saline

Placebo Comparator group

Description:

The surgical bed is irrigated with normal saline

Treatment:

Drug: Irrigation with Normal saline