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

Not Applicable

Completed

• Conditions: Wound Healing
• Interventions: Behavioral: Continuous smoking; Drug: Transdermal nicotine patch; Drug: Placebo patch; Behavioral: Smoking cessation

• Registration Number: NCT00825851
• Lead Sponsor: Bispebjerg Hospital

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.

Study Timeline

• Study Start: 2000-08
• Primary Completion: 2000-12
• Study Completion: 2001-01
• Status Verified: 2009-01
• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-20
• Last Update Submitted: 2009-01-20
• Study First Posted: 2009-01-21
• Last Update Posted: 2009-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous smoking	Continuous smoking	subjects smoke 20 cigarettes per day
smoking cessation and NRT	Transdermal nicotine patch	subjects quit smoking and use transdermal nicotine patch
smoking cessation and NRT	Smoking cessation	subjects quit smoking and use transdermal nicotine patch
smoking cessation and placebo patch	Placebo patch	subjects quit smoking and use placebo patch
smoking cessation and placebo patch	Smoking cessation	subjects quit smoking and use placebo patch

Primary Outcome Measures

Name	Time	Method
wound healing	1, 4, 8, and 12 weeks

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark