CTRI/2021/10/037427招募中3 期
A Phase 3, Open label, multicenter, triple arm, Randomized clinical trial to determine the efficacy of Dehydrated human amnion chorion membrane allograft (AmchoPlast) and Dehydrated human amnion chorion membrane allograft - Polyhexamethylene Biguanide (AmchoPlast PHMB) with Standard Care alone in treatment of acute wounds.
ifeCell International Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients with age between 18 and 55 years.
- •The wound size measures 5 cm2 to 10 cm2 with the likely depth of less than 4 mm.
- •Eligible primary wound types shall be acute superficial/partial thickness, clean, non-contaminated wounds not more than 4 mm in depth, including, but not limited too Burns (thermal/ electrical/ irradiation)
- •Non/minimally exudating wounds
- •Traumatic injuries (abrasion/laceration, ulceration)
- •Donor skin graft area in patient undergoing major surgery
- •The subject is willing to complete all follow-up evaluations required by the study protocol.
- •The subject is to abstain from any other covering or treatment of the wound(s) for the duration of the study unless medically necessary.
- •The subject agrees to abstain from enrolment in any other interventional clinical trial for the duration of the study.
- •The subject and/or guardian is able to read and understand instructions and give informed, voluntary, written consent.
- •The subject is able and willing to follow the protocol requirements.
- •Female of childbearing age with a negative result for a pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial.
排除标准
- •The subject has a microbiologically proven pre-existing local or systemic bacterial infection.
- •The subject is receiving a systemic antibiotic for more than 48 hours prior to grafting.
- •Wound size is less than 5cm2 or greater than 10cm2 or wound depth is more than 4mm.
- •Hepatic disease or altered liver function as defined by ALT or AST value >3 times the upper limit of normal and/or T.Bilirubin >1.5 mg/dL at screening.
- •Renal disease or altered renal function as defined by serum creatinine > 2 mg/dL at screening, or end-stage renal disease.
- •Hemoglobin Male <10.0 or >17.5 g/dL
- •Female <10.0 or 15.5 g/dL
- •Known coagulopathy or platelet disorder, or INR > 1.6 , PTT >38 sec; platelet count < 50,000 at screening
- •Random blood sugar above 160 mg/dL and HbA1c above 6.0 %
- •The subject is known to have a pre-existing, chronic condition that, in the opinion of the Investigator, may interfere with wound healing including but not limited to: current malignancy,
- •uncontrolled diabetes, autoimmune disease or other
- •immunocompromised diseases, renal impairment or ESRD, liver disease, hematological disorders.
- •Patients with a known history of poor compliance with medical treatment.
- •Patients who have been previously randomized into this study, or are presently participating in another clinical trial.
- •Patients on anticoagulant medication will as in any surgical procedure be monitored according to the protocols employed at the enrolling center.
- •Patients diagnosed with autoimmune connective tissues diseases.
- •Non-revascularizable surgical sites.
- •Wound involving weight-bearing surfaces (e.g. heel or forefoot wounds),
- •Any pathology that would limit the blood supply and compromise healing.
- •Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
- •Patients who are pregnant or breastfeeding.
- •Patients who are taking medications that are considered immune
- •system modulators which could affect graft incorporation.
- •Patients who have received negative pressure wound therapy or hyperbaric oxygen therapy in the last 7 days or treatment with other advanced wound care products within the past 30 days.
- •Patients allergic to Vancomycin, Ofloxacin and Amphotericin B and PHMB.
研究者
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