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

November 8, 2013 updated by: Jeanine Wiener-Kronish, Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Chloroprep and biopatch
Both arms are cleaned with chloroprep and a biopatch is placed on each arm.
Experimental: Methylene blue and light treatment
Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.
Procedure: Methylene blue and light treatment
Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Jeanine Wiener-Kronish, MD, MGH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P-002692

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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