跳至主要内容
临床试验/CTRI/2025/07/090502
CTRI/2025/07/090502尚未招募3 期

EFFICACY OF COPPER IMPREGNATED WOUND DRESSING FOR WOUND HEALING IN REPEAT CAESAREAN DELIVERY : A PILOT STUDY

Med Cu Technologies Ltd1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月14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
100
试验地点
1
主要终点
Measure: Mean REEDA (Redness, Edema, Ecchymosis, Discharge, Approximation) score in both the groups on day 7, day 10 and day 30.

研究概览

简要总结

Surgical site infections are complicationsassociated with caesarean delivery which may lead to a substantial effect on the mother’s health. Repeat caesarean have significant association with wound infections.

Copper not only acts as an antimicrobial agent but also stimulates wound healing. Copper impregnated wound dressing has been significantly associated with healing of chronic non healing wounds like diabetic ulcer, pressureulcers, first and second degree wounds and many more.

Hence, we plan to study the effect of copper impregnated wound dressing in repeat caesarean delivery for primary wound healing and risk for surgical site infections following the same.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
0.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women of any age and parity with gestational age more than 28 weeks and undergoing repeat caesarean section, either emergency or elective.
  • Patients who are willing to follow up in UCMS & GTB Hospital.

排除标准

  • Patients with Hepatitis B Hepatitis C HIV or Syphilis.
  • Patients with any dermatological condition around the surgical site Patients allergic to Copper or Wilson’s Disease.
  • Any acute febrile illness.

结局指标

主要结局

Measure: Mean REEDA (Redness, Edema, Ecchymosis, Discharge, Approximation) score in both the groups on day 7, day 10 and day 30.

时间窗: Measure: Mean REEDA (Redness, Edema, Ecchymosis, Discharge, Approximation) score in both the groups on day 7, day 10 and day 30.

次要结局

  • Incidence of SSI among both the groups.(Length of hospital stay.)

研究者

发起方
Med Cu Technologies Ltd
申办方类型
Pharmaceutical industry-Global
责任方
Principal Investigator
主要研究者

Dr. Swarnima Agrawal

University college of medical Sciences and GTB hospital

研究点 (1)

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