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PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Healthy Volunteers.

NCT ID: NCT01981460

Last Updated: 2013-11-11

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

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-07-31

Brief Summary

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We are evaluating the effect of methylene blue and visible light activation on the microbiome of the skin.

Detailed Description

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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

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Light; Therapy, Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chloroprep and biopatch

Both arms are cleaned with chloroprep and a biopatch is placed on each arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Methylene blue and light treatment

Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.

Group Type EXPERIMENTAL

Methylene blue and light treatment

Intervention Type PROCEDURE

Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.

Interventions

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Methylene blue and light treatment

Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Normal individuals without skin problems

Exclusion Criteria

* Smokers
* Diabetics
* Atopic dermatitis
* G-6-PD deficiency
* Eczema
* Other skin conditions
* Allergies to methylene blue or chlorhexadine
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeanine Wiener-Kronish

Chief of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeanine Wiener-Kronish, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Other Identifiers

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2012P-002692

Identifier Type: -

Identifier Source: org_study_id