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

This study has been completed.
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00825851
First received: January 20, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • wound healing [ Time Frame: 1, 4, 8, and 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 20, 2009
Last Updated: January 20, 2009
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013