The Effects of Electronic Cigarettes on the Microcirculation of the Hand

Study Overview
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Brief Summary
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Cigarette smoking is associated with poor wound healing and worse results after hand surgery. Nicotine and cigarette smoke has been shown to affect blood flow in blood vessels in the hand. Patients are increasingly using electronic cigarettes (e-cigarettes) as a method of quitting smoking. E-cigarettes consist of a replaceable nicotine cartridge, a heating element and a battery source. They are able to deliver vaporised nicotine in the absence of other ingredients found in normal cigarettes such as tar and carbon monoxide. Although e-cigarettes lack a lot of the harmful ingredients of regular cigarettes, nicotine still has toxic effects on the body. Nicotine causes the release of chemicals within the body that act to reduce blood flow in small blood vessels of the hand. E-cigarettes remain a controversial topic among healthcare professionals due to the lack of research surrounding them. A recently published literature review identified only three significant studies into the effects of smoking e-cigarettes. All of these studies showed the harmful effects of e-cigarettes on the lungs but to date, there is no published research investigating the effects of e-cigarettes on the blood flow within the small blood vessels of the hand. Currently, we advise patients to quit smoking after they sustain a hand injury to improve healing and recent research suggests that patients should be advised to quit smoking 4 weeks before routine hand surgery. However, there is no guidance on whether we should also advice patients to refrain from using e-cigarettes for this time period. Our aims are to answer the following questions: Do electronic cigarettes have any effect on the blood flow in the hand? Do we need to give cessation advice to patients with hand injuries who smoke electronic cigarettes?

Official Title
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The Effects of Electronic Cigarettes on the Microcirculation of the Hand

Conditions
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Hand Injuries, Elective Hand Surgery

Intervention / Treatment
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* Device: No nicotine e-cigarette
* Device: Low dose nicotine e-cigarette
* Device: High dose nicotine e-cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers between 18-65yrs Volunteers with no co-morbidities Volunteers with no history of oral infections Exclusion Criteria: Volunteers with ongoing co-morbidities requiring medical treatment Volunteers with a history of oral infections e.g Herpes Simplex Virus Volunteers who lack capacity to consent to the study Volunteers who are currently on nicotine replacement therapy Volunteers who have had use of a cigarette or nicotine containing product within 4 hours of beginning the study Volunteers who have previously quit smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-Cigarette<br>3 doses of e-cigarette to be given No nicotine Low dose nicotine High dose nicotine | Device: No nicotine e-cigarette<br> <br> Device: Low dose nicotine e-cigarette<br> <br> Device: High dose nicotine e-cigarette<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microcirculation after smoking different doses of electronic cigarettes | Microcirculation prior to any intervention Microcirculation following inhalation of the e-cigarette with no nicotine cartridge installed (0-30 minutes) Microcirculation following inhalation of the e-cigarette with a low dose nicotine cartridge installed (0-30 minutes) Microcirculation following inhalation of the e-cigarette with a high dose nicotine cartridge installed (0-30 minutes) | 2 hours |