NCT00426972已完成3 期
A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem (Estradiol) in Accelerating the Healing of Split Thickness Skin Graft Donor Sites.
Renovo59 个研究点 分布在 5 个国家目标入组 148 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 59
- 主要终点
- Complete wound closure of skin graft donor site.
研究概览
简要总结
This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness skin graft donor sites in patients aged 18-85 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-85 years who have provided written informed consent.
- •Patients requiring skin grafting due to burns, trauma or chronic venous ulcers, with a donor site expected to be between 20 and 200 cm2 on a non-articulated area.
- •Female patients of child bearing potential who are using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dose.
排除标准
- •Patients with burns involving more than 15% of their total body area.
- •Patients with sepsis, haemodynamic instability requiring pressor support or positive blood microbiology cultures within 48h of surgery.
- •Patients with inhalation injury requiring artificial respiratory assistance.
- •Patients requiring skin grafts following removal of suspicious skin lesions.
- •Patients who have received treatment with systemic steroids during the 30 days prior to surgery.
- •Patients who have received immunosuppressive drugs, radiation or chemotherapy during the three months prior to surgery.
- •Patients with a history of malignancy in the previous three years.
- •Patients with uncontrolled diabetes or diabetic ulcers.
- •Patients with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy.
- •Patients who have previously had skin grafts harvested from the area to be studied.
- •Patients with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
- •Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
- •Patients who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
- •Patients undergoing investigations or changes in management for an existing medical condition.
- •Patients who are or who become pregnant up to and including Day 0 or who are lactating.
- •In the opinion of the Investigator, a patient who is not likely to complete the trial for whatever reason.
结局指标
主要结局
Complete wound closure of skin graft donor site.
次要结局
- Skin graft take
- Adverse events
研究者
研究点 (59)
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