Clinical trial NCT05223127: Aloe Vera on Caesarean Section Wound
Official title: Effect of Aloe Vera on Caesarean Section Wound Healing: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Section
Keywords: Aloe
Cesarean Section
Wound Healing
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Conducting clinical research in line with the literature recommendation, with a method that is low-cost, accessible, easy-to-use, and examined in an evidence-based design related to cesarean section wound, which negatively affects the quality of life of women in the postpartum period, constitutes the original value and our main motivation of the project.

Detailed description: Cesarean section is the delivery of the fetus by incision in the abdominal and uterine wall and is a life-saving method when certain complications arise. While it was initially performed to take the baby alive from the mother who was about to die, it has become an easier operation with the developments in the field of surgery and anesthesia. In this direction, it has become a viable operation even at the request of the mother. However, there is no evidence of benefit to the mother or baby when applied when it is not necessary. In this direction, although the "ideal cesarean section rate" targeted by the World Health Organization since 1985 is between 10-15%, this rate is 37% in 2008, 48% in 2013 and 52% in 2018, according to Turkey Demographic and Health Research (TNSA) data. reported as. This situation brings many problems related to the postpartum period.

Cesarean section is a surgical intervention, not a form of delivery, and as with any surgical intervention, there are many risks. Moreover, the most important difference of cesarean section from any surgical intervention is that the fetus/newborn is also exposed to these risks. In addition, discomfort can be seen depending on the surgical procedure and the incision site after the cesarean section. In the study conducted to examine the cesarean section experiences and post-cesarean care needs of post-natal women; It is stated that almost all puerperant women have problems due to cesarean section, and pain is the leading problem, followed by pain, difficulty in movement, breastfeeding problem due to the incision site, gas, numbness and contraction while walking. It is stated that women who have had cesarean section most frequently experience problems related to their self-care in the early postpartum period, such as pain at the surgery site, difficulty in moving, gas formation, feeding and defecation. If these problems that occur in the mother during the postpartum period are not detected in a timely manner and are not intervened effectively, they can become chronic and negatively affect both the quality of life of the mothers and the health of the newborn.

Aloe vera is seen as an environmentally friendly traditional wound healing agent that increases collagen content and improves cross-links. It contains healing and moisturizing properties with its anti-inflammatory, antiviral, antibacterial, antifungal, antimicrobial properties. When the literature is examined, in the study on the use of aloe vera in cesarean wound healing; It is stated that no side effects of aloe vera gel were observed, the wound healing rate was higher in the first 24 hours in the intervention group, and there was no significant difference between the wound healing scores of the two groups at the end of the 8th day. However, it is recommended to conduct studies with longer interventions on the subject.

Eligibility criteria: Inclusion Criteria:

* In the age range of 18-35,
* Primiparous,
* Gestational week 37 and above,
* Transver incision made,
* Women who volunteered to participate in the study

Exclusion Criteria:

* Body mass index not in the range of 18.5-24.9,
* Having pregnancy complications (such as preeclampsia and diabetes),
* Having chronic diseases (such as anemia, coagulopathy, cardiovascular diseases and respiratory and kidney diseases),
* Smoking or substance use,
* Those who use drugs that affect wound healing (glucocorticoids, anticoagulants, immunosuppressants, antibiotics and chemotherapy drugs before cesarean section),
* Postpartum fever (≥38 ◦C),
* Conditions that cause excessive stretching of the uterus (multiple pregnancy, polyhydramnios),
* Self or baby in need of intensive care,
* Having had a hysterectomy or myomectomy during the operation,
* The operation takes more than 90 minutes,
* Individuals who do not want to withdraw from the study

Primary outcomes:
measure: Wound healing
timeFrame: 12 hours
Secondary outcomes:
measure: Ache
timeFrame: 12 hours
measure: Life quality
timeFrame: 12 hours
Other outcomes:
Locations:
Study officials:
affiliation: KTO Karatay University
name: Hediye KARAKOC, PhD
role: PRINCIPAL_INVESTIGATOR
References: