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

Wound Healing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825851
• Other study ID #: smokaw_3
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: January 20, 2009
• Start date: August 2000
• Est. completion date: January 2001

Study information

• Verified date: January 2009
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 2001
• Est. primary completion date: December 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Wound Healing

Intervention

Drug:
• Transdermal nicotine patch
15mg/16h + 10mg/16h to be used 24h
• Placebo patch

Behavioral:
• Smoking cessation

• Continuous smoking
subjects smoke 20 cigarettes per day

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing		1, 4, 8, and 12 weeks	No