NCT00651820已完成4 期
A Randomized, Double-blind, Paired-Comparison of the Effect of Collagenase Santyl® Ointment on Healing and Scarring Characteristics of 600μm Dermatome Wounds
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Healthpoint
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Time to Complete Wound Closure Collagenase Santyl and Vehicle
研究概览
简要总结
A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent
- •Willing to attend all required study visits
排除标准
- •Known hypersensitivity to Clostridial collagenase
- •Anticoagulants (blood thinners, including aspirin) within two weeks
- •Congenital skin disorder which affects keratinocytes, elastin, or collagen
- •Any dermatologic disease which may be aggravated or provoked by the wounding procedure
- •Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding
- •At risk of keloid or hypertrophic scar formation
- •Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed
- •Any skin disorder which causes delayed healing
- •Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome
- •Taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs
研究组 & 干预措施
Collagenase Santyl Rate of Wound Closure
Experimental
Dermatome-induced skin wounds treated with drug active (collagenase).
干预措施: Collagenase Santyl (Drug)
Vehicle Rate of Wound Closure
Placebo Comparator
Dermatome-induced skin wounds treated with Vehicle alone.
干预措施: Collagenase Santyl Vehicle (Drug)
结局指标
主要结局
Time to Complete Wound Closure Collagenase Santyl and Vehicle
时间窗: 21 days
次要结局
- Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle(9 Months)
研究者
研究点 (1)
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