Wound Healing
Conditions
Brief summary
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.
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.
Interventions
DRUGTransdermal nicotine patch
15mg/16h + 10mg/16h to be used 24h
DRUGPlacebo patch
BEHAVIORALSmoking cessation
BEHAVIORALContinuous smoking
subjects smoke 20 cigarettes per day
Sponsors
The Danish Medical Research Council
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wound healing | 1, 4, 8, and 12 weeks |
Countries
Denmark
Outcome results
None listed