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

N/ACompletedNCT01981460

Massachusetts General Hospital10 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Light; Therapy, Complications

Interventions

Methylene blue and light treatmentPROCEDURE

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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;

Time frame: 1 week

Data from ClinicalTrials.gov

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