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

Not Applicable

Completed

• Conditions: Light; Therapy, Complications
• Interventions: Procedure: Methylene blue and light treatment

• Registration Number: NCT01981460
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-08
• Last Update Submitted: 2013-11-08
• Study First Posted: 2013-11-11
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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;