EUCTR2014-001672-55-IT进行中（未招募）1 期
A multicenter, multinational, randomized, controlled, assessor blinded study, performed in subjects with thermal burns, to evaluate the efficacy and safety of NexoBrid compared to Gel Vehicle and compared to Standard of Care - A multicenter, multinational, randomized, controlled, assessor blinded study, performed in subjects
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 175
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
- •Inclusion Criteria- Patient level
- •1. Males and females; = 18 years of age,
- •2. Thermal burns caused by fire/flame, scalds or contact,
- •3. Patient total burns area = 3% DPT and / or FT,
- •4. Patient total burns area should be = 30% TBSA; SPT, DPT and/or FT in depth,
- •5. Informed consent can be obtained within 84 hours of the burn injury,
- •6. Patients who are willing and able to sign a written consent form.
- •Inclusion Criteria – Wound level
- •1. At least one wound (a continuous burn area) that is =0.5% TBSA (DPT and/or FT) (this minimal wound size should not include face, perineal or genital),
- •All planned target wounds (TWs) should meet the following criteria:
- •2. SPT areas that cannot be demarcated from DPT and FT areas should be less than 50% of the % TBSA of the TW
- •3. Wound’s blisters can be removed/unroofed, as judged by the investigator.
- •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 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Exclusion Criteria- Patient level
- •1. Patients who are unable to follow study procedures and follow up period,
- •2. Modified Baux index14 = 80,
- •3. Patients with burned charred fingers, 3rd degree in depth and possibly devoid of circulation,
- •4. Patients with abraded wound/s that cannot be treated by an enzymatic debrider application (NexoBrid) will be excluded from the study,
- •5. Patients with electrical or chemical burns,
- •6. Patients with circumferential (= 80% of the limb circumference) DPT and/or FT burns defined as Extremities at Risk (EAR) as described in section 11.8,
- •7. The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
- •8. Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of >12 h SSD treatment),
- •9. Patients with pre-enrollment escharotomy,
- •10. Patients with diagnosed infections as described in Section 11.9 of study protocol,
- •11. Diagnosis of smoke inhalation injury,
- •12. Pregnant women (positive pregnancy test) or nursing mothers,
- •13. Poorly controlled diabetes mellitus (HbA1c>11%) in patients with known diabetes as captured in the medical history,
- •14. BMI greater than 39.0 kg/m2 in patients with burns area of up to 15% TBSA or BMI greater than 34.0 kg/m2 in patients with burns area of more than 15% %TBSA,
- •15. ASA greater than 2 (Appendix 13- ASA classification system),
- •16. Cardio-pulmonary disease (MI within 6 months prior to injury, severe pulmonary hypertension,
- •severe COPD or pre-existing oxygen-dependent pulmonary diseases, severe broncho-pneumonia within 1 month prior to injury, steroid dependent asthma or uncontrolled asthma),
- •17. Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins),
- •18. Any conditions that would preclude safe participation in the study or adding further risk to the basic acute burn trauma (such as severe immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, severe cardiovascular disorder, significant pulmonary disorder, significant liver disorder including post alcoholic abuse impaired function or neoplastic disease, blast injury),
- •19. Chronic systemic steroid intake,
- •20. History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain,
- •21. Current (within 12 months prior to screening) suicide attempt,
- •22. Mentally incapacitated adults who are incapable of giving legal consent
- •23. Enrollment in any investigational drug trial within 4 weeks prior to screening,
- •24. Current (within 12 months prior to screening) severe alcohol or drug use disorder (see Definition in section 1.1),
- •25. Prisoners and incarcerated,
- •26. Patients who might depend on the clinical study site or investigator.
研究者
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