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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

January 20, 2009
January 20, 2009
August 2000
December 2000   (final data collection date for primary outcome measure)
wound healing [ Time Frame: 1, 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing
Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Wound Healing
  • Drug: Transdermal nicotine patch
    15mg/16h + 10mg/16h to be used 24h
    Other Name: Nicorette patch
  • Drug: Placebo patch
  • Behavioral: Smoking cessation
  • Behavioral: Continuous smoking
    subjects smoke 20 cigarettes per day
  • Active Comparator: continuous smoking
    subjects smoke 20 cigarettes per day
    Intervention: Behavioral: Continuous smoking
  • Active Comparator: smoking cessation and NRT
    subjects quit smoking and use transdermal nicotine patch
    Interventions:
    • Drug: Transdermal nicotine patch
    • Behavioral: Smoking cessation
  • Placebo Comparator: smoking cessation and placebo patch
    subjects quit smoking and use placebo patch
    Interventions:
    • Drug: Placebo patch
    • Behavioral: Smoking cessation
  • No Intervention: never smokers
    subjects being never smokers and who refrain from smoking
Sorensen LT, Karlsmark T, Gottrup F. Abstinence from smoking reduces incisional wound infection: a randomized controlled trial. Ann Surg. 2003 Jul;238(1):1-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
January 2001
December 2000   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00825851
smokaw_3
No
Copenhagen Wound Healing Center, Bispebjerg Hospital, Bispebjerg Hospital
Bispebjerg Hospital
The Danish Medical Research Council
Principal Investigator: Lars T Sorensen, MD Bispebjerg Hospital
Bispebjerg Hospital
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP