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OpenTrials
Completed

NCT Number: NCT00825851

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.

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Key information

Conditions

Wound Healing

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdermal Nicotine Patch

Drug

15mg/16h + 10mg/16h to be used 24h

Other names: Nicorette patch

Placebo Patch

Drug

smoking cessation

Behavioral

Continuous smoking

Behavioral

subjects smoke 20 cigarettes per day

Primary outcomes

  1. wound healing

    Time frame: 1, 4, 8, and 12 weeks

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • The Danish Medical Research Council

Registry information

Important dates

Study start
2000
Primary completion
2000
Study completion
2001
First posted
Jan 21, 2009
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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