Trials / Completed
CompletedNCT00825851
Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- Bispebjerg Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Transdermal nicotine patch | 15mg/16h + 10mg/16h to be used 24h |
| DRUG | Placebo patch | |
| BEHAVIORAL | Smoking cessation | |
| BEHAVIORAL | Continuous smoking | subjects smoke 20 cigarettes per day |
Timeline
- Start date
- 2000-08-01
- Primary completion
- 2000-12-01
- Completion
- 2001-01-01
- First posted
- 2009-01-21
- Last updated
- 2009-01-21
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00825851. Inclusion in this directory is not an endorsement.