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

Bispebjerg Hospital

Status: Completed

Conditions: Wound Healing

Treatments: Behavioral: Continuous smoking; Drug: Transdermal nicotine patch; Behavioral: Smoking cessation; Drug: Placebo patch

Study type: Interventional

Funder types: Other

Identifiers

NCT00825851

smokaw_3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

78 participants in 4 patient groups, including a placebo group

continuous smoking

Active Comparator group

Description:

subjects smoke 20 cigarettes per day

Treatment:

Behavioral: Continuous smoking

smoking cessation and NRT

Active Comparator group

Description:

subjects quit smoking and use transdermal nicotine patch

Treatment:

Behavioral: Smoking cessation

Drug: Transdermal nicotine patch

smoking cessation and placebo patch

Placebo Comparator group

Description:

subjects quit smoking and use placebo patch

Treatment:

Behavioral: Smoking cessation

Drug: Placebo patch

never smokers

No Intervention group

Description:

subjects being never smokers and who refrain from smoking