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Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla

NCT ID: NCT02314806

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Irrigation with Gentamicin solution

The surgical bed is irrigated with a gentamicin solution

Group Type EXPERIMENTAL

Irrigation with gentamicin solution

Intervention Type DRUG

The surgical bed is irrigated with a gentamicin solution

Irrigation with Clindamycin solution

The surgical bed is irrigated with a clindamycin solution

Group Type EXPERIMENTAL

Irrigation with Clindamycin solution

Intervention Type DRUG

The surgical bed is irrigated with a clindamycin solution

Irrigation with Normal saline

The surgical bed is irrigated with normal saline

Group Type PLACEBO_COMPARATOR

Irrigation with Normal saline

Intervention Type DRUG

The surgical bed is irrigated with normal saline

Interventions

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Irrigation with gentamicin solution

The surgical bed is irrigated with a gentamicin solution

Intervention Type DRUG

Irrigation with Clindamycin solution

The surgical bed is irrigated with a clindamycin solution

Intervention Type DRUG

Irrigation with Normal saline

The surgical bed is irrigated with normal saline

Intervention Type DRUG

Other Intervention Names

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Irrigation of the surgical bed with gentamicin solution Irrigation of the surgical bed with Clindamycin solution Irrigation of the surgical bed with normal saline

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Medicine Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Ruiz-Tovar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General de Elche

References

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Oller I, Ruiz-Tovar J, Cansado P, Zubiaga L, Calpena R. Effect of Lavage with Gentamicin vs. Clindamycin vs. Physiologic Saline on Drainage Discharge of the Axillary Surgical Bed after Lymph Node Dissection. Surg Infect (Larchmt). 2015 Dec;16(6):781-4. doi: 10.1089/sur.2015.020. Epub 2015 Aug 5.

Reference Type DERIVED
PMID: 26244837 (View on PubMed)

Other Identifiers

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HGUE 2014-12

Identifier Type: -

Identifier Source: org_study_id