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Completed

NCT Number: NCT01981460

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

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

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Key information

Conditions

Light; Therapy, Complications

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylene blue and light treatment

Procedure

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

Primary outcomes

  1. Evaluation of the skin microbiome after methylene blue treatment

    Time frame: 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;

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 11, 2013
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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