Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02314806

Enrollment

Registered

2014-12-11

Start date

2013-01-31

Completion date

2014-12-31

Last updated

2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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

Interventions

DRUGIrrigation with gentamicin solution

The surgical bed is irrigated with a gentamicin solution

DRUGIrrigation with Clindamycin solution

The surgical bed is irrigated with a clindamycin solution

DRUGIrrigation with Normal saline

The surgical bed is irrigated with normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

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.

Design outcomes

Primary

Measure	Time frame
Drainage volume discharge	14 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026