EUCTR2006-005092-18-DE进行中（未招募）不适用
A phase 2a, multi-centre, controlled study of the safety and efficacy of wound healing gel I-020502 in patients undergoing autologous meshed skin grafting. - Acute Wounds
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
- •1. Written informed consent by the patient or his/her legal representative.
- •2.Male or female, aged = 18 years
- •3.Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening).
- •4.Patients with burn wound(s) between = 10 % and = 30 % TBSA.
- •5.Patients with a contiguous deep partial thickness/full thickness wound(s) of two comparable sites either contiguous or separate in the same location (e.g. leg) each sized between 1% and 2% TBSA but not more than 400 sqcm.
- •6.Patients who are willing to comply with treatment applications and instructions by the protocol.
- •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
- •1.Females who are pregnant or breast-feeding.
- •2.Patients with known or suspected allergies to any of the components of the wound healing gel I-020502 (e.g. hypersensitivity to bovine proteins).
- •3.Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites.
- •4.Electrical and/or chemical burns.
- •5.Patients that are judged to have significant pulmonary compromise.
- •6.Transcutaneous tissue oxygenation < 90%.
- •7.Clinically significant infections at wound sites.
- •8.Clinically significant systemic infections.
- •9.Suspicion or presence of active systemic or local cancer or tumor of any kind.
- •10.Patients with known immunodeficiency disorders, either congenital or acquired.
- •11.Patients with vascular or skin disorders that directly affect the designated wound site.
- •12.Patients with Diabetes mellitus.
- •13.Patients with chronic malnourishment.
- •14.Chronic treatment with immunosuppressive drugs or systemic corticosteroids within the last 2 months prior to surgery.
- •15.Any other acute or chronic concurrent medical conditions that in the Investigator’s opinion are a contraindication to skin mesh grafting and study participation.
- •16.Participation in another investigational study within 30 days prior to surgery, for investigational devices, or within the last three months for investigational drugs related to wound healing.
研究者
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