ISRCTN18326338终止未知
Role of electrical stimulation in enhancement of cutaneous wound healing and engraftment: Accelerated healing by secondary intention and dermal substitute-assisted tissue regeneration in cutaneous wounds
Accel-Heal® Technologies Ltd0 个研究点目标入组 20 人开始时间: 2021年8月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 20
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
- 性别
- All
入选标准
- •1. Male and female subjects will be included to allow for gender demographic analysis.
- •2. Subjects of either gender who are 18 years and older.
- •3. Subjects who in the opinion of the investigator, are able to fully understand the study requirements and attend all follow-up visits.
- •4. Subjects must provide written informed consent to participate in the study.
- •5. Subjects weighing between 40 and 150kg, with a body mass index of 20-35kg/m2 (as described in the Quetelet’sindexQuetelet’s index – weight (kg)/height²(m)).
排除标准
- •1. Subjects who do not give consent or withdraw their consent to take part in the study.
- •2. Subjects of either gender who are less than 18 years old.
- •3. Subjects who have a history of keloid scarring.
- •4. Subjects who are pregnant or planning to conceive in the next 3 months.
- •5. Subjects who have a chronic or active skin disorder which may be considered to adversely affect the healing rate of the acute wound by the investigator.
- •6. Subjects with any likely wound healing impairment due to a clinically significant medical condition such as renal, hepatic, haematological, neurological or immune disease, including:
- •7. Rheumatoid arthritis
- •8. Chronic renal impairment
- •9. Diabetes Mellitus
- •10. Significant hepatic impairment
- •11. Inadequately or uncontrolled congestive heart failure
- •12. Malignancy – diagnosed or treated within the past 5 years.
- •13. Immunosuppressive, radiation or chemotherapy within the last three months.
- •14. Subjects who take medication known to alter/influence the healing of skin (e.g. steroids)
- •15. Subjects who are receiving formal oral anticoagulant therapy (warfarin).
- •16. Subjects who have received any investigational drugs, or have taken any in the previous month prior to day 0.
- •17. Subjects who have evidence of drug abuse.
- •18. Subjects who have had or are known to have hepatitis B or hepatitis C infection including carriers of hepatitis B surface antigen, hepatitis B core antibodies or hepatitis C antibodies. Previous vaccination against hepatitis B or C is not excluded.
- •19. Subjects who have previously had a positive result to the HIV antibody test, or admit to belong to a high risk group.
- •20. Any subject, who in the opinion of the investigator is unable to fully understand the requirements of the trial, consent or is unable to return for follow-up visits and complete the trial.
- •21. Subjects who become systemically unwell during the research process due to external study causes.
- •22. Subjects who have been involved in other studies in the past month prior to day 0 must discuss the exact details of the previous studies prior to a decision being made on eligibility for inclusion in this trial.
- •23. Subjects with known severe allergies to antibiotics as the skin substitutes may contain antibiotic residuals from processing.
- •24. Patients who are allergic to other amide local anaesthetics.
- •25. Previous MRSA colonisation or infection
- •26. Any bleeding disorders
- •27. Subjects with any heart conditions
- •28. Subjects who have a pacemaker inserted
- •29. Subjects who have epilepsy
- •30. Subjects who currently have cancer
研究者
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