Aloe Vera on Caesarean Section Wound

NCT05223127 | Not Yet Recruiting

• 1 other identifier: Karatay
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cesarean Section

Keywords

Aloe; Cesarean Section; Wound Healing

Outcome Measures

Primary Outcomes (1)

• Wound healing

  It will be assessed using the REEDA scale.

  12 hours

Secondary Outcomes (2)

• Ache

  12 hours

• Life quality

  12 hours

Study Arms (2)

Experimental group

EXPERIMENTAL

Aloe vera

Other: Aloe vera

Control group

NO INTERVENTION

routine care (dressing with dry gauze)

Interventions

Aloe vera OTHER

The leaves of Aloe vera (Aloe barbadensis) will be identified and verified by Selçuk University Faculty of Agriculture. Aloe vera leaves will be washed with antiseptic solution and cut crosswise using gloves and sterile knife. The thick epidermis will be removed from the middle of the leaf. The gel will be obtained from the parenchyma of the thick juicy leaves of aloe vera.

Experimental group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KTO Karatay University: lead

Study Officials

• Hediye KARAKOC, PhD

  KTO Karatay University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hediye KARAKOC, PhD

CONTACT

+905412291726; hediye.bekmezci@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Assistant Professor

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: August 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share