The Effect of Tobacco Products on Wound Healing

NCT04870970 | Active Not Recruiting

• 1 other identifier: STUDY00006048
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Keywords

Wound healing

Outcome Measures

Primary Outcomes (6)

• Cutaneous temperature

  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.

  approximately 7 days

• Cutaneous perfusion

  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."

  approximately 7 days

• Cutaneous oxygenation

  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.

  approximately 7 days

• Immunohistochemistry - markers of inflammation

  CD31 and C68 are stained via standard immunohistochemistry methods on punch biopsied specimens. Unit of measure is cell count.

  approximately 7 days

• Biological Wound Inflammation

  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.

  approximately 7 days

• Tumor necrosis factor (TNF)-alpha

  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.

  approximately 7 days

Study Arms (2)

Tobacco Users

Participants in this group use some form of tobacco.

Non-Tobacco Users

Participants in this group do not use tobacco products.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants must be enrolled in an ongoing study for participation in this sub-study or meet the inclusion/exclusion criteria for participants not enrolled in an active study.

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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)
• Active infection (e.g., influenza, cold, respiratory infection, sinus infection), admission to study will be delayed pending improved health;
• Individuals with extremely sensitive skin that may feel the 45 degrees Celsius is too warm
• Pregnant or breastfeeding or plans to become pregnant
• For participants enrolled in an active Tobacco Research Programs study:
• \- Pregnant or breastfeeding or plans to become pregnant
• Regular use of other tobacco or smoked products (e.g., cigars, pipes, smokeless tobacco, marijuana) in past 6 months;
• Active infection (e.g., influenza, cold, respiratory infection, sinus infection), admission to study will be delayed pending improved health;
• Unstable medical or psychiatric condition
• SMOKERS
• \- Currently smoking at least 10 cigarettes per day;
• \- History of at least 5 years smoking;

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A separate electronic consent form will be used to allow the use of specimens collected (both blood and tissue) for genetic research. Participants can decline the use of their specimens for genetic research but may not be able to participate in the study. The study coordinator will keep a log through REDCap of which participants declined the use of their samples for genetic research to ensure those samples will not be used for genetic research. Participants will also have the option to allow the future use of their de-identified specimens collected for general research, including genetic purposes.

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Dorothy Hatsukami, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 4, 2021
• Study Start: May 18, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)