Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- wound healing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •daily smokers smoking between 15-25 cigarettes per day and never smokers
排除标准
- •chronic medical disease
- •atopic dermatitis or other skin disease
- •pregnancy
- •menopause
- •allergy to dressings or patches
- •current or recent medication with corticosteroids or NSAID
研究组 & 干预措施
smoking cessation and placebo patch
subjects quit smoking and use placebo patch
干预措施: Smoking cessation (Behavioral)
continuous smoking
subjects smoke 20 cigarettes per day
干预措施: Continuous smoking (Behavioral)
smoking cessation and NRT
subjects quit smoking and use transdermal nicotine patch
干预措施: Transdermal nicotine patch (Drug)
smoking cessation and NRT
subjects quit smoking and use transdermal nicotine patch
干预措施: Smoking cessation (Behavioral)
smoking cessation and placebo patch
subjects quit smoking and use placebo patch
干预措施: Placebo patch (Drug)
结局指标
主要结局
wound healing
时间窗: 1, 4, 8, and 12 weeks
次要结局
未报告次要终点