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
About this trial
This is an interventional treatment trial for Light; Therapy, Complications
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
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
NCT ID
NCT01981460
First Posted
November 5, 2013
Last Updated
November 8, 2013
Sponsor
Massachusetts General Hospital
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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