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

Light; Therapy, Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981460
• Other study ID #: 2012P-002692
• Status: Completed
• Phase: N/A
• First received: November 5, 2013
• Last updated: November 8, 2013
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Light; Therapy, Complications

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No