Hand InjuriesNCT02206737
The Effects of Electronic Cigarettes on the Microcirculation of the Hand
A study testing No nicotine e-cigarette, Low dose nicotine e-cigarette and High dose nicotine e-cigarette in people with Hand Injuries and Elective Hand Surgery, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries, Elective Hand Surgery
- What is being tested?
- No nicotine e-cigarette, Low dose nicotine e-cigarette and High dose nicotine e-cigarette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers between 18-65yrs
- Volunteers with no co-morbidities
- Volunteers with no history of oral infections
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Chelsea and Westminster Hospital
London, London, SW10 9NH
Matthew J Pywell, MBBS
About this study
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.
Read more
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?
- Conditions
- Hand Injuries, Elective Hand Surgery
- Being tested
- No nicotine e-cigarette, Low dose nicotine e-cigarette, High dose nicotine e-cigarette
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No nicotine e-cigaretteDevice
Low dose nicotine e-cigaretteDevice
High dose nicotine e-cigaretteDevice
| Study group | Role | What they receive |
|---|---|---|
| E-Cigarette | Experimental | 3 doses of e-cigarette to be given No nicotine Low dose nicotine High dose nicotine Receives: Device: No nicotine e-cigarette; Device: Low dose nicotine e-cigarette; Device: High dose nicotine e-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206737
- Sponsor's protocol ID
- CW14025
- Status last verified
- Jul 2014
- First submitted
- 31 Jul 2014
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23141048Fischer-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.
PubMed 22565620Petschke 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.
PubMed 16896901van 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.
PubMed 1737221Bullen 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.
PubMed 24029165Palazzolo 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.
PubMed 24350225
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Electronic Cigarettes on the Microcirculation of the Hand
- ClinicalTrials.gov ID
- NCT02206737
- Acronym / sponsor ID
- CW14025
- Conditions
- Hand Injuries, Elective Hand Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (estimated)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-Cigarette | Experimental | Device: No nicotine e-cigarette, Device: Low dose nicotine e-cigarette, Device: High dose nicotine e-cigarette3 doses of e-cigarette to be given No nicotine Low dose nicotine High dose nicotine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteers between 18-65yrs
- Volunteers with no co-morbidities
- Volunteers with no history of oral infections
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No nicotine e-cigarette | Device | E-Cigarette |
| Low dose nicotine e-cigarette | Device | E-Cigarette |
| High dose nicotine e-cigarette | Device | E-Cigarette |
Primary outcome
Microcirculation after smoking different doses of electronic cigarettes
Time frame: 2 hours
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Background: PubMed 23141048Wei 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.
- Background: PubMed 22565620Fischer-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.
- Background: PubMed 16896901Petschke 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.
- Background: PubMed 1737221van 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.
- Background: PubMed 24029165Bullen 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.
- Background: PubMed 24350225Palazzolo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No nicotine e-cigarette, Low dose nicotine e-cigarette and High dose nicotine e-cigarette in people with Hand Injuries and Elective Hand Surgery, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew J Pywell, MBBS (07540644102, matthew.pywell@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microcirculation after smoking different doses of electronic cigarettes (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02206737, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.