What is the purpose of this study?
The purpose of this research study is to see if different types of tobacco products (such as smokeless tobacco, electronic cigarettes, combustible cigarettes and medicinal nicotine) have an effect on wound healing. We will look at this effect by creating two small wounds on the inside of your arm and watching the wound for up to 10 days. We will look at other parts of wound healing by taking images, blood flow measurements and by testing different molecules in your blood and oral cells. The relationship between these different tobacco products and wound healing is not well understood, and there is some evidence that some of these products may have a negative effect on wound healing. We wish to explore this relationship.
This study is recruiting both tobacco users and non-tobacco users.
How often are the clinic visits?
The frequency of the clinic visits can vary depending on whether or not you are already enrolled in an eligible research study at the Tobacco Research Programs. This is called a "parent" study. If you are already enrolled in a parent study, the length of this research study will depend on the length of the parent study and when your study visits for the parent study are scheduled. Most visits for this study will be on the same day as the parent study. However, this is not guaranteed and we may need you to come in on days that are not on the same day as the parent study visits.
If you are not enrolled in a parent study, the length of this research study will be at least three weeks. There will be a remote online orientation visit and 3 in person study visits including a baseline visit, study visit 1, study visit 2 and a follow up visit. There will be about a week between study visit 1 and 2 and the follow up visit can be scheduled 3 days to 3 weeks after the study visit 2.
What will I be doing in the study?
You will be asked to allow a medical professional to take a set of 3mm punch biopsies of your inner arm, on two occasions, on study visit 1 and study visit 2. A punch biopsy removes a skin sample from the surface of your inner arm and is completed by using a circular tool to remove a small section of the skin including deeper layers. You will be asked to allow trained research staff to take digital and thermographic images of your punch biopsy wound and opposite un-wounded arm, calves and facial profiles at study visit 1, 2, and at the follow up visit. A thermographic image will be captured using a special camera that is able to measure the temperature of your skin. You will be asked to allow research staff to take oral cell samples from your mouth on study visit 1 and 2. This will be completed by swabbing the inside of your mouth with a soft brush. We will ask you to allow a trained laboratory technician or nurse to complete a blood draw (2.2 tablespoons) at the baseline visit and study visit 2. Finally, you will have the option to complete up to two “laser Doppler sessions” at study visit 1 and 2 depending on machine availability. Laser Doppler technologies use electrodes or sensors to record different blood flow measurements.
Will I be compensated?
If you agree to take part in this research study, we will pay you up to $260 for your time and effort. You will be paid $10 at the baseline visit, $40 at study visit 1, $50 at study visit 2 and, $60 at the follow up visit for completion of the study. If you are enrolled in a parent study and are already being paid for a blood draw or follow up visit, you will not be paid as a part of this research study. If you complete the optional laser Doppler sessions, you will be paid $50 for each completed session.
What should I do if I'm interested?
Contact Anna Wilson at 612-873-5329 or email@example.com