The Effects of Electronic Cigarettes on the Microcirculation of the Hand
Primary Purpose
Hand Injuries, Elective Hand Surgery
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
No nicotine e-cigarette
Low dose nicotine e-cigarette
High dose nicotine e-cigarette
Sponsored by
About this trial
This is an interventional basic science trial for Hand Injuries
Eligibility Criteria
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
Sites / Locations
- Chelsea and Westminster HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
E-Cigarette
Arm Description
3 doses of e-cigarette to be given No nicotine Low dose nicotine High dose nicotine
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02206737
First Posted
July 31, 2014
Last Updated
July 31, 2014
Sponsor
Chelsea and Westminster NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02206737
Brief Title
The Effects of Electronic Cigarettes on the Microcirculation of the Hand
Official Title
The Effects of Electronic Cigarettes on the Microcirculation of the Hand
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chelsea and Westminster NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries, Elective Hand Surgery
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
E-Cigarette
Arm Type
Experimental
Arm Description
3 doses of e-cigarette to be given No nicotine Low dose nicotine High dose nicotine
Intervention Type
Device
Intervention Name(s)
No nicotine e-cigarette
Intervention Type
Device
Intervention Name(s)
Low dose nicotine e-cigarette
Intervention Type
Device
Intervention Name(s)
High dose nicotine e-cigarette
Primary Outcome Measure Information:
Title
Microcirculation after smoking different doses of electronic cigarettes
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)
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew J Pywell, MBBS
Phone
07540644102
Email
matthew.pywell@nhs.net
Facility Information:
Facility Name
Chelsea and Westminster Hospital
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew J Pywell, MBBS
12. IPD Sharing Statement
Citations:
PubMed Identifier
23141048
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.
Results Reference
background
PubMed Identifier
22565620
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.
Results Reference
background
PubMed Identifier
16896901
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.
Results Reference
background
PubMed Identifier
1737221
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.
Results Reference
background
PubMed Identifier
24029165
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.
Results Reference
background
PubMed Identifier
24350225
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.
Results Reference
background
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The Effects of Electronic Cigarettes on the Microcirculation of the Hand
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