Effect of Topical Diltiazem Plus Fusidic Acid Versus Fusidic Acid Alone on Episiotomy Healing, Pain, and Resumption of Sexual Activity: A Randomized Controlled Trial in Azadi Teaching Hospital
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- wound healing
研究概览
简要总结
The goal of this clinical trial is to learn if diltiazem gel combined with fucidic acid cream works better than fucidic acid cream alone to prevent surgical site infection following episiotomy repair. It will also learn about the safety of this regimen. The main questions it aims to answer are:
Does diltiazem gel combined with fucidic acid cream lower the incidence of surgical site infection? What medical problems do participants have when taking this regimen? Researchers will compare whether diltiazem gel combined with fucidic acid cream versus the fucidic acid cream alone to see if the first protocol works better?
Participants will:
Apply diltiazem gel combined with fucidic acid cream twice/day for 10 days Visit the clinic on days 3, 7, and 10 for checkups and tests Keep a diary of their symptoms and the number of times they use the regimen.
详细描述
Group 1 received sequential topical diltiazem gel followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone. In Group 1, diltiazem gel was first applied to the sutured episiotomy twice daily for 10 days post delivery. After approximately 15 minutes, fusidic acid cream was applied to the same area. In Group B, fusidic acid cream alone was applied to the episiotomy wound twice daily for 10 days postpartum. Both groups received the same routine postpartum care instructions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants were randomly assigned in a 1:1 ratio to one of two groups. The random sequence was generated before enrollment by computer-generated random numbers, and allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes. Because the intervention regimen involved two sequential applications in one group and a single topical application in the other group, participant blinding was not feasible. The study was therefore conducted as an assessor-blinded trial; the investigator who measured REEDA and VAS outcomes at follow-up visits was not involved in treatment allocation and was unaware of group assignment.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparous women
- •Singleton term pregnancy.
- •Vaginal delivery with mediolateral episiotomy.
- •Willingness to participate and provide informed consent.
排除标准
- •Known hypersensitivity to diltiazem or fusidic acid.
- •Pre-existing local perineal infection.
- •Chronic systemic disease likely to impair wound healing, including uncontrolled diabetes or immunosuppressive conditions.
研究组 & 干预措施
diltiazem and fusidic acid
patients in this group received sequential topical diltiazem gel 2% followed by fusidic acid cream>
干预措施: Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone (Drug)
fusidic acid cream alone
Patients in this group received topical fusidic acid cream alone
干预措施: Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone (Drug)
结局指标
主要结局
wound healing
时间窗: 10 days
The primary outcome was wound healing as assessed by the REEDA scale on postpartum. It measures five key indicators-Redness, Edema, Ecchymosis, Discharge, and Approximation-with a lower score indicating better healing and higher scores showing impaired healing.
次要结局
- pain intensity(10 days)
研究者
Alaa Nadhim Hameed
doctor
University of Kirkuk