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

NCT01981460 | Completed

• 1 other identifier: 2012P-002692
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Light; Therapy, Complications

Outcome Measures

Primary Outcomes (1)

• 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;

  1 week

Study Arms (2)

Chloroprep and biopatch

NO INTERVENTION

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

Methylene blue and light treatment

EXPERIMENTAL

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

Procedure: Methylene blue and light treatment

Interventions

Methylene blue and light treatment PROCEDURE

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

Methylene blue and light treatment

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal individuals without skin problems

You may not qualify if:

• Smokers
• Diabetics
• Atopic dermatitis
• G-6-PD deficiency
• Eczema
• Other skin conditions
• Allergies to methylene blue or chlorhexadine

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Interventions

Methylene Blue

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jeanine Wiener-Kronish, MD

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Anesthesia

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 11, 2013

Record last verified: 2013-11