CTRI/2014/07/004732招募中4 期
â??multicentric, open-label, safety and efficacy study of Fibroheal® (CentellaAsiatica herbal wound healing sheet) in split- thickness skin graft donor sitetreatment and partial thickness wounds caused by Trauma/burns.
SericareDivision of Healthline Pvt Ltd Funded by SIBRI DBT0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
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
- •Subjects to be included in the study must meet the following eligibility criteria:
- •1. Age: 18 -55 years
- •2. Subjects with wounds caused by trauma / burns, donor site grafts
- •3. Wound size at least 10 cm x 10 cm; depth 0.15 -0.45 mm (0.006-0.018 inches)
- •4. Eligible to receive dressing on an inpatient basis for 2 weeks and on outpatient basis for 2
- •5. Not currently on any other interventional treatment.
- •6. The subject and /or guardian are able understand instructions and are willing to give written
- •informed consent and comply with the requirements of the study protocol.
- •7. The subject is willing to complete all follow-up evaluations required by the study protocol
- •8. Subjects non-allergic to the investigational product
- •9. The subject is to abstain from any other treatment of the wound(s) for the duration of the
- •study unless medically necessary
- •10. The subject agrees to abstain from enrollment in any other clinical trial for the duration of the
排除标准
- •1. History of or current other inflammatory diseases
- •2. Infection, allergy on the tested area.
- •3. Chronic wound showing signs of infections with copious slough and purulent discharge
- •4. Subject on topical medication for wound less than 1 week.
- •5. Cutaneous disease which may influence the study result.
- •6. Chronic illness which may influence the cutaneous state.
- •7. Subject on oral corticosteroid with dose > 10mg/day.
- •8. Subject participated in other cosmetic or therapeutic trial less than 4 weeks ago.
- •9. Any underlying medical illness including, liver disease or history of alcoholism, HIV or
- •any other serious medical illness.
- •10. Pregnant and lactating women
- •11. Donor sites other than the thigh
研究者
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