Smoking, Tobacco Smoking, Tobacco Use
Conditions
Keywords
Wound healing
Brief summary
The purpose of this study is to evaluate the effect of various tobacco products (including but not limited to combustible cigarettes, medicinal nicotine, electronic cigarettes, and smokeless tobacco) on cutaneous wound healing. There will also be a non- smoking control group. This study will be designed as a pilot study. The majority of individuals will be recruited from ongoing studies at the University of Minnesota - Tobacco Research Programs.
Detailed description
Participants will be recruited from ongoing studies will some recruitment of tobacco users and non-smoking controls outside of ongoing studies. In this prospective, cohort study of various tobacco users and non-smokers, a punch biopsy model of wound healing will be used to determine the effects of various tobacco products on inflammatory response and oxidative stress response to wounding: 1. Clinical wound inflammation as assessed by: 1. Thermography, 2. Clinical assessment, 3. Laser Doppler Technologies, 4. Transcutaneous oxygen assessment 2. Biological wound inflammation as assessed by: 1. Cytokine profiles, 2. Histology, 3. Genetic assessment, 4. Epigenetic evaluation 3. Systemic inflammation as assessed by: 1. Biomarkers, 2. Cell counts
Interventions
None listed
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. For participants NOT enrolled in an active Tobacco Research Programs study: Inclusion criteria: * In good physical health with no unstable or serious medical conditions as determined by the licensed medical professional; * In stable and good mental health (i.e. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse) as determined by the licensed medical professional; The remaining inclusion criteria is different depending on the type of tobacco product the individual uses: A) Non Smokers * Has consumed less than 100 cigarettes in his or her lifetime. * Combustible Tobacco Users * History of at least 5 years smoking * Smokers will have exclusively smoked at least 5 cigarettes per day for a minimum of 4 days per week for the past year B) E-Cigarette Users * Have not smoked cigarettes in the last month * Has exclusively used e-cigarettes for at least 3 months * Has at least 5 instances of using an e cigarettes per day for a minimum of 4 days per week C) Medicinal Nicotine Users * Have not smoked cigarettes in the last month * Has at least 5 instances of using medicinal nicotine per day for a minimum of 4 days per week D) Smokeless Tobacco Users \- Have not smoked cigarettes in the last month \- Has at least 5 instances of using smokeless tobacco per day for a minimum of 4 days per week E) Combustible Tobacco and E-Cigarette Dual Users * Has used a combination of combustible tobacco products and e-cigarettes for the past month. * Has at least 5 instances of using a combination of combustible tobacco and e-cigarettes per day for a minimum of 4 days per week F) Combustible Tobacco and Medicinal Nicotine Dual Users * Has used a combinations of combustible tobacco products and e-cigarettes for the past month. * Has at least 5 instances of using a combination of combustible tobacco and medicinal nicotine per day for a minimum of 4 days per week
Exclusion criteria
* Any tattoos on the medial upper arm (note that one medial upper arm can have a tattoo, but at least one side does not have a tattoo). * History of delayed wound healing. * Intention to quit normal tobacco product use in the next three months. * Excessive drinking (more than 21 alcoholic drinks per week) * Taking exclusionary medications (including anti-inflammatory agents) unstable dosing of medications, or unstable control of symptoms for ongoing medical conditions (medications or conditions that would impact biomarkers or patient safety to be determined by the licensed medical professional at each site). * Active infection (e.g., influenza, cold, respiratory infection, sinus infection), admission to study will be delayed pending improved health; * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cutaneous temperature | approximately 7 days | Cutaneous temperature is measured using in infrared thermographic camera (FLIR T460 Infrared Thermal Imaging Camera, FLIR Systems, Inc., Wilsonville, OR). Images will be analyzed using a camera-specific software (FLIR Tools) that interrogates cutaneous temperature points of the image. The units are software-determined, arbitrary units that are standardized within the FLIR imaging system but do not correspond to standard units of measure. |
| Cutaneous perfusion | approximately 7 days | Cutaneous perfusion is measured using Laser Doppler Technologies (PeriFlux 6000, Perimed AB, Stockholm, Sweden). Tissue oxygenation is measured in the capillaries only. Perfusion is measured in arbitrary system defined "perfusion units." |
| Cutaneous oxygenation | approximately 7 days | Cutaneous oxygenation is measured using Laser Doppler Technologies (PeriFlux 6000, Perimed AB, Stockholm, Sweden). Tissue oxygenation is measured in the capillaries only. Oxygenation is measured in mmHg. |
| Immunohistochemistry - markers of inflammation | approximately 7 days | CD31 and C68 are stained via standard immunohistochemistry methods on punch biopsied specimens. Unit of measure is cell count. |
| Biological Wound Inflammation | approximately 7 days | IL-1b, 6 and 10 are measured using standard immunoassays and reported in units of pg/ml. These cytokines will be measured in both the skin and blood. |
| Tumor necrosis factor (TNF)-alpha | approximately 7 days | TNF-alpha is measured using standard immunoassays and reported in units of pg/ml. This cytokine will be measured in both the skin and blood. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDorothy Hatsukami, PhD
University of Minnesota
Outcome results
None listed