Effect of Onion Extract Nanoparticle Gel Phonophoresis on Postsurgical Scar of Cesarean Section.

Effect of Onion Extract Nanoparticle Gel Phonophoresis on Postsurgical Scar of Cesarean Section

Cesarean section is one of the most common abdominal operations performed on women. The cesarean section rate is rising rapidly and continuously in many parts of the world. The cesarean-section surgery leaves a scar that requires special care. A horizontal skin incision approximately 10-15 cm long is usually performed during the procedure. Apart from the skin, the following: subcutaneous tissue, fascia, peritoneum, and uterine muscle are cut leaving traces in the form of scars and accompanying ailments, on the one hand, such as pain, tenderness, and hypersensitivity to stimuli, and on the other, limitations, such as contractures or impairment of tissue mobility

Study Overview

• Status: Recruiting
• Conditions: Scar; Previous Cesarean Section
• Intervention / Treatment: Other: Phonophoresis; Other: sham ultrasound

Detailed Description

All this may directly influence the patient's quality of life. There is also a significant negative impact on the psychological and social aspects of life, caused by the appearance of an unesthetic scar. Improper wound healing affects the area Therefore, it can affect the aesthetic appearance of the abdomen and cause, among others, posture asymmetry, gait disturbance, and pain in the lumbar spine. A growing number of patients are dissatisfied with the appearance of their scars. The efficacy of many existing prophylactic and therapeutic strategies has been proven through extensive use, also data on several approaches have been contradictory regarding the efficacy and side effects. Topical therapies have their advantages; specifically, increased adherence, the localized delivery of the product, and the reduced impact of first-pass metabolism. Onion extract contains a range of phenolic anti-oxidant and anti-inflammatory compounds and was originally used for treating full and partial-thickness burns; however, more recently these have been trialed for treating hypertrophic and keloid scarring, and healing wounds. onion extract plays the main role in reducing scars by inhibiting fibroblast proliferation and collagen production. onion extract is also believed to have anti-inflammatory and antimicrobial effects. Some studies on the preventive and treatment effectiveness of onion extract on hypertrophic scars demonstrated its capability to improve scar appearance Ultrasound-based therapy has shown to be a viable option for abnormal scarring. It has been shown to reduce the growth of keloids or postoperative scars and to facilitate the penetration of anti-scarring drugs into the dermis ). Advantages of phonophoresis include noninvasiveness, good compliance, low cost, and minimal gastrointestinal side effects

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Menna Mohmed, doctoral; Phone Number: 01118758578; Email: Mennamohmed.PT@o6u.edu.eg
• Study Contact Backup: Name: Heba Haridy, doctoral; Phone Number: 01117671712; Email: Heba.Ahmed.PT@o6u.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Heba
    • Contact: menna abbass; Phone Number: 01202299885; Email: mennaabbass.pt@o6u.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Their ages will be ≥18 years old. All women had given birth via elective abdominal transversal C-section for the first time.

All women suffering from Postsurgical Scar Of Cesarean-Section about 2-3 months post-surgery.

All women will provide an informed consent form agreeing to participate and publication of the study results

Exclusion Criteria:

Any pathological conditions or associated injuries affect the result of the study.

Skin disease. Cognitive and psychological impairment. Patients have implanted electronic devices, such as cardiac pacemakers, to prevent ultrasound interference.

Women with diabetes, cardiovascular problems, or a previous history of any disorder may alter sensation and delay the healing process which counteracts the study's goal.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: phonophoresis group; Twenty women will receive onion extract phonophoresis (3 sessions/week) for 12 weeks in addition to deep friction massage.	Other: Phonophoresis; Pulsed ultrasound will be used at a frequency of 1 MHz with an intensity of 0.5 W/ cm2 for 5 minutes.
Sham Comparator: control group; Twenty women will receive sham ultrasound (3 sessions/week) for 12 weeks in addition to deep friction massage.	Other: sham ultrasound; sham ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Vancouver scar scale	Assesses four characteristics of vascularity, pigmentation, pliability, and height The larger the The larger the total score, the worse the scar . Normal skin (zero score)	12 weeks
Tonometer	Tonometer The measurement area is placed directly under the tissue tonometer. A blunt piston is pressed into the tissue by the weight, and the resulting output reading is shown. The measurements are proportional to the tissue's pliability. All measurement procedures will be explained to each woman in both groups.	12 weeks

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Principal Investigator: Heba Haridy, doctoral, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 000114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No