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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01981460
• Collaborator: (none)
• Enrollment: 10
• Arms: 2
• Duration (Months): 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Light; Therapy, Complications	Procedure: Methylene blue and light treatment	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Normal Volunteers
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Evaluation of the skin microbiome after methylene blue treatment [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;

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeanine Wiener-Kronish, Chief of Anesthesia, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01981460
• Other Study ID Numbers: 2012P-002692
• First Posted: Nov 11, 2013
• Last Update Posted: Nov 11, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Infections; Methylene Blue

Study Results

No Results Posted as of Nov 11, 2013