Henna for Marking the Skin During Ultrasound-guided Localization

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Christine Lee, M.D., Ph.D.	Open for enrollment	Contact information: Samuel Jang M.D. Jang.Samuel@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Samuel Jang M.D.

Jang.Samuel@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials