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Henna for Marking the Skin During Ultrasound-guided Localization

Overview

Información sobre este estudio

The skin is commonly marked with an ink-based pen prior to and during ultrasound guided procedures. However, ink markings on the skin can affected by routine skip preperation. Additional limitations include its durability if the marking needs to last multiple days and its inability to write over ultrasound gel.

This is a feasibility study evaluating henna's ability to mark the skin under specified conditions, and it will not be evaluating the safety or efficacy for a medical purpose. As a result, henna is not listed in this application as a study drug or device. Henna will be applied on the human skin over ultrasound gel. Then its durability and resistence to alcohol-based antiseptic solutions containing chlorhexidine gluconate will be evaluated.

Following further discussion with ORRS, it was determined this is a feasibility study, which is not evaluating the safety or efficacy of henna for a medical purpose. Therefore an IND or IDE is not required. The IRB application has been updated accordingly.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Adult volunteers, ≥ 18 years:
    • 5 volunteers with Fitzpatrick skin type I-II;
    • 5 volunteers with Fitzpatrick skin type III-IV;
    • 5 volunteers with Fitzpatrick skin type V-VI.

Exclusion Criteria:

 

  • Unable to come to all follow up visits.
  • Skin tattoo on the distal upper extremities.
  • Prior surgery in the distal upper extremities.
  • Prior allergic reaction to henna.

Eligibility last updated 3/14/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Christine Lee, M.D., Ph.D.

Abierto para la inscripción

Contact information:

Samuel Jang M.D.

Jang.Samuel@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20564380

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