A phase 2b, multi-centre, randomized, intra-patient-controlled dose-finding study of I-020502 in patients undergoing autologous meshed skin grafting. - N/A

Kuros Biosurgery AG0 个研究点目标入组 150 人开始时间: 2009年6月8日最近更新: 2012年3月19日

适应症

试验速览

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•1.Written informed consent by the patient.
•2.Male or female patients, aged = 18 years.
•3.Female with childbearing potential with a negative pregnancy test within 10 days prior to surgery who agrees to use an acceptable birth control method (hormonal or UID) until day 28 post surgery.
•4.Patients with burn wound(s) up to 50% TBSA elected for autologous mesh grafting of a meshing ratio 1:3.
•5.Patients with a 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.
•6.Patients who are considered to be able to comply with 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

•1.Females who are pregnant or breast-feeding.
•2.Patients with known or suspected allergies to any of the components of I-020502 (e.g. hypersensitivity to bovine proteins).
•3.Digits, head, genitalia, palms of hands, soles of feet, and
•face as test sites.
•4.Electrical and/or chemical burns.
•5.Clinically significant infections at wound sites.
•6.Clinically significant systemic infections.
•7.History or suspicion or presence of systemic or local cancer or tumor of any kind.
•8.Patients previously treated with PDGF.
•9.Patients with vascular or skin disorders that directly affect the designated wound site.
•10.Patients with HbA1c < 7%.
•11.Patients with chronic malnourishment.
•12.Chronic treatment with immunosuppressive drugs, systemic corticosteroids or other chronic treatments influencing wound healing within the last 2 months prior to surgery.
•13.Any other acute or chronic concurrent medical conditions that in the Investigator’s opinion compromise study participation.
•14.Participation in another investigational study within 30 days prior to surgery for investigational devices, or within 3 months prior to surgery for investigational drugs.

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