Breast CancerPhase 3NCT02314806
Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla
A Phase 3 study testing Irrigation with gentamicin solution, Irrigation with Clindamycin solution and Irrigation with Normal saline in people with Breast Cancer, run by Hospital General Universitario Elche.
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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Irrigation with gentamicin solution, Irrigation with Clindamycin solution and Irrigation with Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- allergy to any of the antibiotic drugs used
- chronic renal failure due to possible toxicity of gentamicin
- patients undergoing a modified radical mastectomy.
About this study
Official title: Effect of Gentamicin Versus Clindamycin Versus Normal Saline Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume
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
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Irrigation with gentamicin solution, Irrigation with Clindamycin solution, Irrigation with Normal saline
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation with gentamicin solutionDrug
Also called Irrigation of the surgical bed with gentamicin solution
The surgical bed is irrigated with a gentamicin solution
Irrigation with Clindamycin solutionDrug
Also called Irrigation of the surgical bed with Clindamycin solution
The surgical bed is irrigated with a clindamycin solution
Irrigation with Normal salineDrug
Also called Irrigation of the surgical bed with normal saline
The surgical bed is irrigated with normal saline
| Study group | Role | What they receive |
|---|---|---|
| Irrigation with Gentamicin solution | Experimental | The surgical bed is irrigated with a gentamicin solution Receives: Drug: Irrigation with gentamicin solution |
| Irrigation with Clindamycin solution | Experimental | The surgical bed is irrigated with a clindamycin solution Receives: Drug: Irrigation with Clindamycin solution |
| Irrigation with Normal saline | Placebo comparator | The surgical bed is irrigated with normal saline Receives: Drug: Irrigation with Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drainage volume discharge
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Jaime Ruiz-Tovar, MD, PhD, Principal investigator, Hospital General de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314806
- Sponsor's protocol ID
- HGUE 2014-12
- Status last verified
- Dec 2014
- First submitted
- 7 Dec 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26244837
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gentamicin Versus Clindamycin Versus Normal Saline Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume
- ClinicalTrials.gov ID
- NCT02314806
- Acronym / sponsor ID
- HGUE 2014-12
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Irrigation with Gentamicin solution | Experimental | Drug: Irrigation with gentamicin solutionThe surgical bed is irrigated with a gentamicin solution |
| Irrigation with Clindamycin solution | Experimental | Drug: Irrigation with Clindamycin solutionThe surgical bed is irrigated with a clindamycin solution |
| Irrigation with Normal saline | Placebo comparator | Drug: Irrigation with Normal salineThe surgical bed is irrigated with normal saline |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- allergy to any of the antibiotic drugs used
- chronic renal failure due to possible toxicity of gentamicin
- patients undergoing a modified radical mastectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigation with gentamicin solutionAlso: Irrigation of the surgical bed with gentamicin solutionThe surgical bed is irrigated with a gentamicin solution | Drug | Irrigation with Gentamicin solution |
| Irrigation with Clindamycin solutionAlso: Irrigation of the surgical bed with Clindamycin solutionThe surgical bed is irrigated with a clindamycin solution | Drug | Irrigation with Clindamycin solution |
| Irrigation with Normal salineAlso: Irrigation of the surgical bed with normal salineThe surgical bed is irrigated with normal saline | Drug | Irrigation with Normal saline |
Primary outcome
Drainage volume discharge
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
- Derived from this study: PubMed 26244837Oller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Ruiz-Tovar, MD, PhD principal investigator
Hospital General de Elche
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irrigation with gentamicin solution, Irrigation with Clindamycin solution and Irrigation with Normal saline in people with Breast Cancer, run by Hospital General Universitario Elche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drainage volume discharge (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02314806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.