EUCTR2006-005049-12-DE进行中（未招募）不适用
A Double Blind, Placebo Controlled Trial to Investigate the Efficacy of Zesteem in Accelerating the Healing of Split Thickness Skin Graft Donor Sites - Zesteem in accelerating the healing of split thickness skin graft donor sites.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Renovo Ltd
- 入组人数
- 296
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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. For the purposes of the protocol, acceptable method(s) of contraception will be defined as consistently and correctly used implants, injectables, combined oral contraceptives, sexual abstinence or a vasectomised partner.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 a history of peripheral arterial disease.
- •- 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.
研究者
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