The Effects of Electronic Cigarettes on the Microcirculation of the Hand

NCT02206737 | Unknown DMC

• 1 other identifier: CW14025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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:

1. 1.Do electronic cigarettes have any effect on the blood flow in the hand?
2. 2.Do we need to give cessation advice to patients with hand injuries who smoke electronic cigarettes?

Conditions

Hand Injuries; Elective Hand Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

E-Cigarette

EXPERIMENTAL

3 doses of e-cigarette to be given No nicotine Low dose nicotine High dose nicotine

Device: No nicotine e-cigarette; Device: Low dose nicotine e-cigarette; Device: High dose nicotine e-cigarette

Interventions

No nicotine e-cigarette DEVICE

E-Cigarette

Low dose nicotine e-cigarette DEVICE

E-Cigarette

High dose nicotine e-cigarette DEVICE

E-Cigarette

Eligibility Criteria

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

You may qualify if:

• Volunteers between 18-65yrs
• Volunteers with no co-morbidities
• Volunteers with no history of oral infections

You may not qualify if:

• 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

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

Study Sites (1)

Chelsea and Westminster Hospital

London, London, SW10 9NH, United Kingdom

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Matthew J Pywell, MBBS

CONTACT

07540644102; matthew.pywell@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 1, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Last Updated: August 1, 2014

Record last verified: 2014-07

Locations

GB (1)