Skin ColonizationPhase 4NCT00389558
Antiseptic Use and Dressing Application
A Phase 4 study testing disinfection efficacy using Biseptine and disinfection efficacy using Amukin in people with Skin Colonization and Catheterization, run by Maternite Regionale Universitaire at 1 site in France.
Trial summary
The purposes of the study are: 1. To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI). 2. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Skin Colonization, Catheterization, Bacterial Infection
- What is being tested?
- disinfection efficacy using Biseptine and disinfection efficacy using Amukin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Oct 2008
- Phase
- Phase 4
- 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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All infants admitted to the Neonatal Intensive Care Unit
- Epicutaneocavous catheter insertion indication
Who cannot join
- Epicutaneocavous catheter not inserted within the Unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention
The purposes of the study are:
- To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).
- To evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the EPI site.
Read the detailed description
Epicutaneocavous catheter is a significant risk factor for nosocomial infection in newborn infants. These infections have been related to local bacterial colonisation. Therefore thorough disinfection should lower the risk of nosocomial infection. However, the local efficacy of antiseptic use has not yet been clearly evaluated in this situation.
- Conditions
- Skin Colonization, Catheterization, Bacterial Infection
- Being tested
- disinfection efficacy using Biseptine, disinfection efficacy using Amukin
- Keywords
- Skin colonization, Antiseptic, Epicutaneocavous catheter dressing, Infant
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disinfection efficacy using BiseptineProcedure or surgery
Also called Biseptine
Detersion and antiseptic application when changing catheter dressing
disinfection efficacy using AmukinProcedure or surgery
Also called Amukin
Detersion and antiseptic application when changing catheter dressing
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Biseptine Receives: Procedure: disinfection efficacy using Biseptine |
| 1 | Active comparator | Amukin Receives: Procedure: disinfection efficacy using Amukin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy on skin colonization of two commercially available antiseptics
Measured: 2 weeks
Secondary outcomes (1)
In case of nosocomial infection, relationship with skin bacteria
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionOct 2008
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 Skin ColonizationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternite Regionale Universitaire
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Michel HASCOET, MD, Study director, University of NANCY, FranceMonique LUX, Pharmacist, Principal investigator, Maternite Regionale Universitaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389558
- Sponsor's protocol ID
- MRAP190406
- Status last verified
- Sep 2009
- First submitted
- 17 Oct 2006
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahieu LM, De Dooy JJ, De Muynck AO, Van Melckebeke G, Ieven MM, Van Reempts PJ. Microbiology and risk factors for catheter exit-site and -hub colonization in neonatal intensive care unit patients. Infect Control Hosp Epidemiol. 2001 Jun;22(6):357-62. doi: 10.1086/501913.
PubMed 11519913
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention
- ClinicalTrials.gov ID
- NCT00389558
- Acronym / sponsor ID
- MRAP190406
- Conditions
- Skin Colonization, Catheterization, Bacterial Infection
- Keywords
- Skin colonization, Antiseptic, Epicutaneocavous catheter dressing, Infant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Maternite Regionale UniversitaireUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Oct 2006 (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 purposes of the study are:
- To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).
- To evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the EPI site.
Detailed description
Epicutaneocavous catheter is a significant risk factor for nosocomial infection in newborn infants. These infections have been related to local bacterial colonisation. Therefore thorough disinfection should lower the risk of nosocomial infection. However, the local efficacy of antiseptic use has not yet been clearly evaluated in this situation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: disinfection efficacy using BiseptineBiseptine |
| 1 | Active comparator | Procedure: disinfection efficacy using AmukinAmukin |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All infants admitted to the Neonatal Intensive Care Unit
- Epicutaneocavous catheter insertion indication
Key exclusion criteria (1 listed)
- Epicutaneocavous catheter not inserted within the Unit
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 |
|---|---|---|
| disinfection efficacy using BiseptineAlso: BiseptineDetersion and antiseptic application when changing catheter dressing | Procedure or surgery | 2 |
| disinfection efficacy using AmukinAlso: AmukinDetersion and antiseptic application when changing catheter dressing | Procedure or surgery | 1 |
Primary outcome
Efficacy on skin colonization of two commercially available antiseptics
Time frame: 2 weeks
1 secondary outcome
In case of nosocomial infection, relationship with skin bacteria
Time frame: 2 weeks
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 21 Sep 2009.
- Background: PubMed 11519913Mahieu LM, De Dooy JJ, De Muynck AO, Van Melckebeke G, Ieven MM, Van Reempts PJ. Microbiology and risk factors for catheter exit-site and -hub colonization in neonatal intensive care unit patients. Infect Control Hosp Epidemiol. 2001 Jun;22(6):357-62. doi: 10.1086/501913.
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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.
Jean-Michel HASCOET, MD study director
University of NANCY, France
Monique LUX, Pharmacist principal investigator
Maternite Regionale Universitaire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing disinfection efficacy using Biseptine and disinfection efficacy using Amukin in people with Skin Colonization and Catheterization, run by Maternite Regionale Universitaire at 1 site in France.
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 1 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 21 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy on skin colonization of two commercially available antiseptics (time frame: 2 weeks). 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 NCT00389558, 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 21 Sep 2009.