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Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00825851
First Posted: January 21, 2009
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Danish Medical Research Council
Information provided by:
Bispebjerg Hospital
  Purpose
The aim was to determine the wound healing capacity in healthy never smokers and smokers who continue to smoke, or quit smoking using transdermal nicotine patch versus placebo patch.

Condition Intervention
Wound Healing Drug: Transdermal nicotine patch Drug: Placebo patch Behavioral: Smoking cessation Behavioral: Continuous smoking

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • wound healing [ Time Frame: 1, 4, 8, and 12 weeks ]

Enrollment: 78
Study Start Date: August 2000
Study Completion Date: January 2001
Primary Completion Date: December 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: continuous smoking
subjects smoke 20 cigarettes per day
Behavioral: Continuous smoking
subjects smoke 20 cigarettes per day
Active Comparator: smoking cessation and NRT
subjects quit smoking and use transdermal nicotine patch
Drug: Transdermal nicotine patch
15mg/16h + 10mg/16h to be used 24h
Other Name: Nicorette patch
Behavioral: Smoking cessation
Placebo Comparator: smoking cessation and placebo patch
subjects quit smoking and use placebo patch
Drug: Placebo patch Behavioral: Smoking cessation
No Intervention: never smokers
subjects being never smokers and who refrain from smoking

Detailed Description:
Two wound healing models were applied: the excisional skin biopsy model to study wound histology and the suction blister model to study epidermal regeneration and skin transudate. In addition blood sampling was made to validate compliance to the study arms and to study systemic markers of collagen metabolism and oxidative stress. In addition, wound infections and wound ruptures were recorded post hoc as complications to the excisional skin biopsy model were not expected to occur.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • daily smokers smoking between 15-25 cigarettes per day and never smokers

Exclusion Criteria:

  • chronic medical disease
  • atopic dermatitis or other skin disease
  • pregnancy
  • menopause
  • allergy to dressings or patches
  • current or recent medication with corticosteroids or NSAID
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825851


Locations
Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
The Danish Medical Research Council
Investigators
Principal Investigator: Lars T Sorensen, MD Bispebjerg Hospital
  More Information

Publications:
Responsible Party: Copenhagen Wound Healing Center, Bispebjerg Hospital, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00825851     History of Changes
Other Study ID Numbers: smokaw_3
First Submitted: January 20, 2009
First Posted: January 21, 2009
Last Update Posted: January 21, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Wounds and Injuries
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action