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临床试验/CTRI/2024/12/078280
CTRI/2024/12/078280尚未招募3 期

Inventing a novel topical application called-DVolve SilverSoothe ScarCream- A Revolutionary Formulation for Scar Reduction and Wound Healing

Saveetha Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月28日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
the effectiveness of a novel cream in promoting wound healing and reducing scar formation in patients with first-degree burns

研究概览

简要总结

This is a prospective study done to evaluate the efficacy and safety of the cream in 30 first degree burn patients in Saveetha Medcial college and hospital. Patients with first-degree burns confirmed by medical assessment. Age 18 years and above. Willing to participate in the study and provide informed consent. Available for follow-up assessments as required. Able to understand and comply with study procedures are included in the study. Patients with burns other than first-degree (e.g., second-degree, third-degree burns).Age below 18 years. Inability to provide informed consent (e.g., cognitive impairment), Presence of pre-existing conditions that may affect burn healing (e.g., diabetes, immunocompromised status), Pregnancy, as hormonal changes may impact burn healing, Unwillingness or inability to comply with study procedures or follow-up assessments are excluded from the study. Patient surveys or questionnaires administered to gather subjective feedback on pain levels, scar appearance, and overall satisfaction with the cream’s effectiveness. Objective measurements such as scar dimensions, tissue elasticity, and wound healing rates obtained through clinical assessments conducted by trained healthcare professionals Laboratory analyses of biological samples (e.g., skin biopsies) to evaluate histological changes, cytokine levels, and other biomarkers associated with wound healing and scar formation. Documentation of adverse events, medication adherence, and other relevant clinical data obtained from patient medical records and follow-up appointments.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with first-degree burns confirmed by medical assessment.
  • Willing to participate in the study and provide informed consent.
  • Available for follow-up assessments as required and able to understand and comply with study procedures.

排除标准

  • Patients with burns other than first-degree e.g., second-degree, third-degree burns.
  • Age below 18 years.
  • Inability to provide informed consent e.g., cognitive impairment, Presence of pre-existing conditions that may affect burn healing e.g., diabetes, immunocompromised status, Pregnancy, as hormonal changes may impact burn healing.
  • Unwillingness or inability to comply with study procedures or follow-up assessments.

结局指标

主要结局

the effectiveness of a novel cream in promoting wound healing and reducing scar formation in patients with first-degree burns

时间窗: 0, 3, 6, 9, 12, 15 days

次要结局

  • A. Evaluate the efficacy of the novel cream in relieving pain associated with first-degree burns(0, 3, 6, 9, 12, 15 days)

研究者

发起方
Saveetha Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR Vasireddy Divya

Saveetha Medical College and Hospital

研究点 (1)

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