Light; Therapy, ComplicationsNCT01981460
PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Healthy Volunteers.
A study testing Methylene blue and light treatment in people with Light; Therapy, Complications, run by Massachusetts General Hospital.
Trial summary
We are evaluating the effect of methylene blue and visible light activation on the microbiome of the skin. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Light; Therapy, Complications
- What is being tested?
- Methylene blue and light treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jul 2013
- Phase
- Interventional
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal individuals without skin problems
Who cannot join
- Smokers
- Diabetics
- Atopic dermatitis
- G-6-PD deficiency
- Eczema
- Other skin conditions
- Allergies to methylene blue or chlorhexadine
About this study
Official title: PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Normal Volunteers
We are evaluating the effect of methylene blue and visible light activation on the microbiome of the skin.
Read the detailed description
Antiseptics are routinely utilized to prevent infections of vascular catheters. We are evaluating the addition of methylene blue and light activation on skin to determine whether this inexpensive and non-toxic treatment can decrease skin pathogens and prevent blood stream infections of long-term vascular catheters. This is a pilot study of normal volunteers to determine the effect on the microbiome of the addition of methylene blue and light activation on antiseptic-treated skin.
- Conditions
- Light; Therapy, Complications
- Being tested
- Methylene blue and light treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene blue and light treatmentProcedure or surgery
Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Chloroprep and biopatch | No intervention | Both arms are cleaned with chloroprep and a biopatch is placed on each arm. |
| Methylene blue and light treatment | Experimental | Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals. Receives: Procedure: Methylene blue and light treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the skin microbiome after methylene blue treatment
We compared the two arms of each subject --one arm treated with chloraprep and a biopatch [routine treatment of skin] to the routine treatment with the addition of methylene blue spray and light activation. The microbiome of both skin areas were assessed before and after the routine treatment and the treatment with the addition of methylene blue therapy;
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Light; Therapy, ComplicationsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanine Wiener-Kronish, Massachusetts General Hospital
- Investigators
- Jeanine Wiener-Kronish, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981460
- Sponsor's protocol ID
- 2012P-002692
- Status last verified
- Nov 2013
- First submitted
- 5 Nov 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Normal Volunteers
- ClinicalTrials.gov ID
- NCT01981460
- Acronym / sponsor ID
- 2012P-002692
- Conditions
- Light; Therapy, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Nov 2013 (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.
We are evaluating the effect of methylene blue and visible light activation on the microbiome of the skin.
Detailed description
Antiseptics are routinely utilized to prevent infections of vascular catheters. We are evaluating the addition of methylene blue and light activation on skin to determine whether this inexpensive and non-toxic treatment can decrease skin pathogens and prevent blood stream infections of long-term vascular catheters. This is a pilot study of normal volunteers to determine the effect on the microbiome of the addition of methylene blue and light activation on antiseptic-treated skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroprep and biopatch | No intervention | –Both arms are cleaned with chloroprep and a biopatch is placed on each arm. |
| Methylene blue and light treatment | Experimental | Procedure: Methylene blue and light treatmentMethylene blue and light treatment for 17 minutes are done twice over 1 week intervals. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal individuals without skin problems
Key exclusion criteria (7 listed)
- Smokers
- Diabetics
- Atopic dermatitis
- G-6-PD deficiency
- Eczema
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 |
|---|---|---|
| Methylene blue and light treatmentMethylene blue and light treatment for 17 minutes are done twice over 1 week intervals. | Procedure or surgery | Methylene blue and light treatment |
Primary outcome
Evaluation of the skin microbiome after methylene blue treatment
Time frame: 1 week
We compared the two arms of each subject --one arm treated with chloraprep and a biopatch [routine treatment of skin] to the routine treatment with the addition of methylene blue spray and light activation. The microbiome of both skin areas were assessed before and after the routine treatment and the treatment with the addition of methylene blue therapy;
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 Nov 2013.
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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.
Jeanine Wiener-Kronish, MD principal investigator
MGH
Questions about this trial
What is this clinical trial studying?
A study testing Methylene blue and light treatment in people with Light; Therapy, Complications, run by Massachusetts General Hospital.
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 1 inclusion and 7 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 Nov 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Evaluation of the skin microbiome after methylene blue treatment (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2013.