<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02206737</url>
  </required_header>
  <id_info>
    <org_study_id>CW14025</org_study_id>
    <nct_id>NCT02206737</nct_id>
  </id_info>
  <brief_title>The Effects of Electronic Cigarettes on the Microcirculation of the Hand</brief_title>
  <official_title>The Effects of Electronic Cigarettes on the Microcirculation of the Hand</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chelsea and Westminster NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chelsea and Westminster NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cigarette smoking is associated with poor wound healing and worse results after hand surgery.&#xD;
      Nicotine and cigarette smoke has been shown to affect blood flow in blood vessels in the&#xD;
      hand.&#xD;
&#xD;
      Patients are increasingly using electronic cigarettes (e-cigarettes) as a method of quitting&#xD;
      smoking. E-cigarettes consist of a replaceable nicotine cartridge, a heating element and a&#xD;
      battery source. They are able to deliver vaporised nicotine in the absence of other&#xD;
      ingredients found in normal cigarettes such as tar and carbon monoxide.&#xD;
&#xD;
      Although e-cigarettes lack a lot of the harmful ingredients of regular cigarettes, nicotine&#xD;
      still has toxic effects on the body. Nicotine causes the release of chemicals within the body&#xD;
      that act to reduce blood flow in small blood vessels of the hand.&#xD;
&#xD;
      E-cigarettes remain a controversial topic among healthcare professionals due to the lack of&#xD;
      research surrounding them. A recently published literature review identified only three&#xD;
      significant studies into the effects of smoking e-cigarettes. All of these studies showed the&#xD;
      harmful effects of e-cigarettes on the lungs but to date, there is no published research&#xD;
      investigating the effects of e-cigarettes on the blood flow within the small blood vessels of&#xD;
      the hand.&#xD;
&#xD;
      Currently, we advise patients to quit smoking after they sustain a hand injury to improve&#xD;
      healing and recent research suggests that patients should be advised to quit smoking 4 weeks&#xD;
      before routine hand surgery. However, there is no guidance on whether we should also advice&#xD;
      patients to refrain from using e-cigarettes for this time period.&#xD;
&#xD;
      Our aims are to answer the following questions:&#xD;
&#xD;
        1. Do electronic cigarettes have any effect on the blood flow in the hand?&#xD;
&#xD;
        2. Do we need to give cessation advice to patients with hand injuries who smoke electronic&#xD;
           cigarettes?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Anticipated">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Microcirculation after smoking different doses of electronic cigarettes</measure>
    <time_frame>2 hours</time_frame>
    <description>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)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hand Injuries</condition>
  <condition>Elective Hand Surgery</condition>
  <arm_group>
    <arm_group_label>E-Cigarette</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 doses of e-cigarette to be given No nicotine Low dose nicotine High dose nicotine</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>No nicotine e-cigarette</intervention_name>
    <arm_group_label>E-Cigarette</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low dose nicotine e-cigarette</intervention_name>
    <arm_group_label>E-Cigarette</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High dose nicotine e-cigarette</intervention_name>
    <arm_group_label>E-Cigarette</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteers between 18-65yrs&#xD;
&#xD;
          -  Volunteers with no co-morbidities&#xD;
&#xD;
          -  Volunteers with no history of oral infections&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers with ongoing co-morbidities requiring medical treatment&#xD;
&#xD;
          -  Volunteers with a history of oral infections e.g Herpes Simplex Virus&#xD;
&#xD;
          -  Volunteers who lack capacity to consent to the study&#xD;
&#xD;
          -  Volunteers who are currently on nicotine replacement therapy&#xD;
&#xD;
          -  Volunteers who have had use of a cigarette or nicotine containing product within 4&#xD;
             hours of beginning the study&#xD;
&#xD;
          -  Volunteers who have previously quit smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Matthew J Pywell, MBBS</last_name>
    <phone>07540644102</phone>
    <email>matthew.pywell@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Matthew J Pywell, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Wei DH, Strauch RJ. Smoking and hand surgery. J Hand Surg Am. 2013 Jan;38(1):176-9; quiz 179. doi: 10.1016/j.jhsa.2012.08.018. Epub 2012 Nov 7. No abstract available.</citation>
    <PMID>23141048</PMID>
  </reference>
  <reference>
    <citation>Fischer-Rasokat U, Spyridopoulos I, Walter J, Honold J, Zeiher AM, Fichtlscherer S. Microvascular dysfunction and pulse wave reflection characterize different vascular pathologies in patients at cardiovascular risk. Vasa. 2012 May;41(3):192-9. doi: 10.1024/0301-1526/a000185.</citation>
    <PMID>22565620</PMID>
  </reference>
  <reference>
    <citation>Petschke FT, Engelhardt TO, Ulmer H, Piza-Katzer H. [Effect of cigarette smoking on skin perfusion of the hand]. Chirurg. 2006 Nov;77(11):1022-6. doi: 10.1007/s00104-006-1216-1. German.</citation>
    <PMID>16896901</PMID>
  </reference>
  <reference>
    <citation>van Adrichem LN, Hovius SE, van Strik R, van der Meulen JC. Acute effects of cigarette smoking on microcirculation of the thumb. Br J Plast Surg. 1992 Jan;45(1):9-11. doi: 10.1016/0007-1226(92)90106-8.</citation>
    <PMID>1737221</PMID>
  </reference>
  <reference>
    <citation>Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, Walker N. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013 Nov 16;382(9905):1629-37. doi: 10.1016/S0140-6736(13)61842-5. Epub 2013 Sep 9.</citation>
    <PMID>24029165</PMID>
  </reference>
  <reference>
    <citation>Palazzolo DL. Electronic cigarettes and vaping: a new challenge in clinical medicine and public health. A literature review. Front Public Health. 2013 Nov 18;1:56. doi: 10.3389/fpubh.2013.00056.</citation>
    <PMID>24350225</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 31, 2014</last_update_submitted>
  <last_update_submitted_qc>July 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hand Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02206737
org study id: CW14025
nct id: NCT02206737
lead sponsor: 
has dmc: Yes
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:

        1. Do electronic cigarettes have any effect on the blood flow in the hand?

        2. Do we need to give cessation advice to patients with hand injuries who smoke electronic
           cigarettes?
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Microcirculation after smoking different doses of electronic cigarettes
time frame: 2 hours
description: 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)
arm group label: E-Cigarette
arm group type: Experimental
description: 3 doses of e-cigarette to be given No nicotine Low dose nicotine High dose nicotine
intervention type: Device
intervention name: No nicotine e-cigarette
arm group label: E-Cigarette
intervention type: Device
intervention name: Low dose nicotine e-cigarette
arm group label: E-Cigarette
intervention type: Device
intervention name: High dose nicotine e-cigarette
arm group label: E-Cigarette
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew J Pywell, MBBS
phone: 07540644102
email: matthew.pywell@nhs.net
facility: 
status: Recruiting
investigator: 
country: United Kingdom
citation: Wei DH, Strauch RJ. Smoking and hand surgery. J Hand Surg Am. 2013 Jan;38(1):176-9; quiz 179. doi: 10.1016/j.jhsa.2012.08.018. Epub 2012 Nov 7. No abstract available.
PMID: 23141048
citation: Fischer-Rasokat U, Spyridopoulos I, Walter J, Honold J, Zeiher AM, Fichtlscherer S. Microvascular dysfunction and pulse wave reflection characterize different vascular pathologies in patients at cardiovascular risk. Vasa. 2012 May;41(3):192-9. doi: 10.1024/0301-1526/a000185.
PMID: 22565620
citation: Petschke FT, Engelhardt TO, Ulmer H, Piza-Katzer H. [Effect of cigarette smoking on skin perfusion of the hand]. Chirurg. 2006 Nov;77(11):1022-6. doi: 10.1007/s00104-006-1216-1. German.
PMID: 16896901
citation: van Adrichem LN, Hovius SE, van Strik R, van der Meulen JC. Acute effects of cigarette smoking on microcirculation of the thumb. Br J Plast Surg. 1992 Jan;45(1):9-11. doi: 10.1016/0007-1226(92)90106-8.
PMID: 1737221
citation: Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, Walker N. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013 Nov 16;382(9905):1629-37. doi: 10.1016/S0140-6736(13)61842-5. Epub 2013 Sep 9.
PMID: 24029165
citation: Palazzolo DL. Electronic cigarettes and vaping: a new challenge in clinical medicine and public health. A literature review. Front Public Health. 2013 Nov 18;1:56. doi: 10.3389/fpubh.2013.00056.
PMID: 24350225
responsible party type: Sponsor
mesh term: Hand Injuries
mesh term: Nicotine