The Effect of Boric Acid Wet Dressing on Perineal Wound Healing and Pain Level in Postpartum Perineal Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Perineal Wound Healing (REEDA Scale Score)
研究概览
简要总结
Perineal trauma, including episiotomy and first- or second-degree perineal tears, is a common postpartum condition associated with pain and delayed wound healing after vaginal birth. This randomized controlled trial aims to evaluate the effects of boric acid wet dressing on postpartum perineal wound healing and pain compared with normal saline wet dressing and routine perineal care. Ninety-one women with perineal trauma are randomly assigned to one of three study groups. The primary outcome is perineal wound healing assessed using the REEDA Scale. Secondary outcomes include general and activity-related perineal pain assessed using the Visual Analog Scale (VAS).
详细描述
Perineal trauma, occurring as episiotomy or lacerations during vaginal delivery, is a significant postpartum issue associated with pain and delayed recovery. Boric acid is a micronutrient with established antiseptic, antifungal, and antibacterial properties that supports tissue repair by modulating fibroblast activity and reducing oxidative stress. This study is designed as a three-arm randomized controlled trial to evaluate the clinical efficacy of topical boric acid wet dressings compared to normal saline and routine dry care.
All participants, regardless of their group, received standardized face-to-face education on perineal hygiene, covering topics such as hand hygiene, proper cleaning techniques, and signs of infection.
The boric acid group receives a 2% boric acid wet dressing applied to the perineal area for 15 minutes twice daily for seven consecutive days in addition to routine postpartum care. The normal saline group receives a 0.9% normal saline wet dressing using the same procedure and frequency in addition to routine postpartum care. The routine care group receives standard postpartum perineal care without additional wet dressing.
Outcome assessments are performed at baseline (approximately the second postpartum hour), at the twelfth postpartum hour, at hospital discharge, and between postpartum days 10 and 15.
The primary outcome measure is perineal wound healing evaluated using the REEDA Scale. Secondary outcome measures include general perineal pain and activity-related pain during sitting, walking, breastfeeding, urination, and defecation assessed using the Visual Analog Scale (VAS).
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
- None
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
- •Women aged 18 years or older. Vaginal birth with episiotomy or first- or second-degree perineal tear. No signs or symptoms of vaginal infection. No pregnancy or postpartum complications requiring additional treatment. Able to communicate in Turkish. Willing to participate and provide written informed consent.
排除标准
- •Third- or fourth-degree obstetric perineal tears. No perineal trauma after vaginal birth. Presence of vaginal infection. Pregnancy or postpartum complications requiring medical treatment. Inability to communicate in Turkish. Withdrawal of consent during the study. Failure to complete follow-up assessments.
研究组 & 干预措施
Boric Acid Group
Participants in this group received a 2% boric acid wet dressing applied to the perineal trauma area for 15 minutes, twice daily. The application was initiated in the hospital and continued for two days following discharge
干预措施: 2% Boric Acid Wet Dressing (Other)
Boric Acid Group
Participants in this group received a 2% boric acid wet dressing applied to the perineal trauma area for 15 minutes, twice daily. The application was initiated in the hospital and continued for two days following discharge
干预措施: Routine Care Group (Behavioral)
Normal Saline Group
Participants in this group received a 0.9% sodium chloride (normal saline) wet dressing applied to the perineal trauma area for 15 minutes, twice daily. The application protocol was identical to the boric acid group
干预措施: 0.9% Normal Saline Wet Dressing (Other)
Normal Saline Group
Participants in this group received a 0.9% sodium chloride (normal saline) wet dressing applied to the perineal trauma area for 15 minutes, twice daily. The application protocol was identical to the boric acid group
干预措施: Routine Care Group (Behavioral)
Routine Care Group
Participants in this group followed the standard clinical routine of the facility, which consists of keeping the perineal area clean and dry. They received only perineal hygiene education without any wet dressing application
干预措施: Routine Care Group (Behavioral)
结局指标
主要结局
Perineal Wound Healing (REEDA Scale Score)
时间窗: From the 2nd hour postpartum (baseline) up to the follow-up visit (between postpartum days 10 and 15)
Perineal wound healing was assessed using the REEDA Scale, which evaluates five parameters: Redness, Edema, Ecchymosis, Discharge, and Approximation. Each parameter is scored from 0 to 3, with a total score ranging from 0 to 15. Higher scores indicate greater tissue trauma and poorer wound healing
次要结局
- Perineal Pain Intensity (Visual Analog Scale - VAS)(From the initial postpartum assessment (baseline) up to the follow-up visit (between postpartum days 10 and 15))
研究者
Esra Çalışkan
Principal Investigator
Saglik Bilimleri Universitesi