Safety and Efficacy of Carbon Selenium Complex in Second Degree Burns: A Randomized Clinical Trial

Parsroos Biotechnology Company0 个研究点目标入组 200 人开始时间: 待定最近更新: 2018年2月22日

适应症

试验速览

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•Inclusion Criteria: Each involved patient should be stable in condition and not need resuscitation; Thermal flame or scald injury; Admitted within 24 hours after the injury; Clean noninfected wound as diagnosed by the attending physician; The wounds with comparable size and treatment prior to the screening visit; The size of the burn wounds to be assessed is required to be at least 15 cm2 but no more than 300 cm2; In case of more than one burned wound in the same individual as described above, the wound with the greatest surface area will be selected for study; The burn area less than 20% and more than 1% total body surface area (TBSA); Age from 18 to 65 years; Weight up to 100 kg; Patients will be eligible for the study if written informed consent is obtained from each participant.

•Burn injury occurrence >24 h prior to commencement of treatment; Full-thickness burns; Wounds noted to be contaminated or infected; Burns in special areas such as the face, fingers, axillary, perineal or inguinal region, deep body folds, or a distinctive adipose tissue region and finally, massive burns in joints; Drug allergy histories or known hypersensitivity to silver sulfadiazine or any other ingredient of the study medications; Contraindications for the use of topical preparations containing silver sulfadiazine; Pregnancy; Alcohol or drug abuse; Significant organ dysfunctions such as renal failure, CHF, and liver dysfunction; Cancer; Vascular diseases; Immunosuppressive disorders; Inhalation injury; Simultaneous burn and trauma; Abnormal liver enzymes and total bilirubin > 1.5 times of normal upper limit

发起方

Parsroos Biotechnology Company