THE EFFECT OF USING CHLORHEXIDINE GLUCONATE AND POVIDONE IODINE SOLUTION ON THE HEALING PROCESS BEFORE A CESAREAN SECTION
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- To determine that cleaning the incision site with 2% CG solution (containing 70% alcohol) is more effective than PI in the wound healing process.
研究概览
简要总结
The study was planned to evaluate the effects of two most commonly used antiseptic products and showering on the healing process, such as wound healing and postoperative maternal comfort in cesarean section. A randomized controlled trial included 102 pregnant women from February and May of 2021. They were randomly divided into povidone iodine (PI) group (A) chlorhexidine gluconate (CG) group (B) and CG shower (C) operated by two Gynecology and Obstetrics physician. Data from the in house blinding study to avoid bias and follow-up of the women was done for 7 day duration following postnatal to assess postoperative for comfort, pain, wound complications.
详细描述
Purpose and type of research This study was designed as a randomized controlled trial to examine the effect of preoperative use of CG and PI on the postoperative healing process and maternal postpartum comfort.
Hypothesis H1: Cleaning the incision area with a 2% CG solution (containing 70% alcohol) is more effective in the wound healing process than PI.
H2: Taking a shower with a 2% CG solution (containing 70% alcohol) 6 hours before, and cleaning the incision area, is more effective in the wound healing process than PI.
H3: Cleaning the incision area with a 2% CG solution (containing 70% alcohol) produces a higher postpartum comfort level than PI.
H4: Taking a shower 6 hours before with a 2% CG solution (containing 70% alcohol), and cleaning the incision area, produces a higher postpartum comfort level than PI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The inclusion criteria included the absence of systemic and chronic disease (thyroid disease, gestational diabetes, gestational hypertension or allergy), no history of previous abdominal surgery, a newborn baby follow-up with no health problems that would hinder the breastfeeding process, 37 gestational weeks of pregnancy and above, pregnant women with a low-risk pregnancy, those with a body mass index between 20 and 30 who were at least a primary school graduate, and who were between 19 to 40 years of age.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •hospitalized with a planned cesarean section scheduled between the study dates
- •volunteer woman
排除标准
- •participants who dont meet the inclusion criteria
结局指标
主要结局
To determine that cleaning the incision site with 2% CG solution (containing 70% alcohol) is more effective than PI in the wound healing process.
时间窗: 4 months
To determine that using the Incision site evaluation form (ISEF). This form was used to evaluate erythema, warmth, oedema, discharge and wound opening. The score of form is between 0-3 for each item, and the total score is between 0-15. According to the form, a high score is interpreted as a poor recovery.
次要结局
- To determine that cleaning the incision site with 2% CG solution (containing 70% alcohol) provides a higher level of postpartum comfort than PI(4 months)
- To determine that showering with 2% CG solution (containing 70% alcohol) 6 hours ago and cleaning the incision area provides a higher level of postpartum comfort compared to PI.(4 months)
- To determine that taking a shower with 2% CG solution (containing 70% alcohol) 6 hours before and cleaning the incision site is more effective than PI in the wound healing process.(4 months)
研究者
öznur tiryaki
Assistant Professor
Sakarya University