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

Primary Purpose

Light; Therapy, Complications

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Methylene blue and light treatment
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Light; Therapy, Complications

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Chloroprep and biopatch

    Methylene blue and light treatment

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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;

    Secondary Outcome Measures

    Full Information

    First Posted
    November 5, 2013
    Last Updated
    November 8, 2013
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01981460
    Brief Title
    PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Healthy Volunteers.
    Official Title
    PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Normal Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Light; Therapy, Complications

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Chloroprep and biopatch
    Arm Type
    No Intervention
    Arm Description
    Both arms are cleaned with chloroprep and a biopatch is placed on each arm.
    Arm Title
    Methylene blue and light treatment
    Arm Type
    Experimental
    Arm Description
    Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.
    Intervention Type
    Procedure
    Intervention Name(s)
    Methylene blue and light treatment
    Intervention Description
    Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.
    Primary Outcome Measure Information:
    Title
    Evaluation of the skin microbiome after methylene blue treatment
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeanine Wiener-Kronish, MD
    Organizational Affiliation
    MGH
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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