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

NCT06658444 | Recruiting DMC

• 1 other identifier: 000114
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Scar; Previous Cesarean Section

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

phonophoresis group

EXPERIMENTAL

Twenty women will receive onion extract phonophoresis (3 sessions/week) for 12 weeks in addition to deep friction massage.

Other: Phonophoresis

control group

SHAM COMPARATOR

Twenty women will receive sham ultrasound (3 sessions/week) for 12 weeks in addition to deep friction massage.

Other: sham ultrasound

Interventions

Phonophoresis OTHER

Pulsed ultrasound will be used at a frequency of 1 MHz with an intensity of 0.5 W/ cm2 for 5 minutes.

phonophoresis group

sham ultrasound OTHER

sham ultrasound

control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (2)

Heba

Cairo, Egypt

RECRUITING

Heba

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Cicatrix

Interventions

Phonophoresis

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Heba Haridy, doctoral

  Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heba Haridy, doctoral

CONTACT

01117671712; Heba.Ahmed.PT@o6u.edu.eg

Menna mohmed, doctoral

CONTACT

01118758578; Mennamohmed.PT@o6u.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of basic science department

Model Details: Ultrasound-based therapy has proven to be a viable option for treating abnormal scarring. It has been shown to reduce the growth of keloids or postoperative scars. Phonophoresis's advantages include noninvasiveness, good compliance, low cost, and minimal gastrointestinal side effects. Onion extracts were 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 scar through the inhibition of fibroblast proliferation and collagen production.

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: September 12, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 1, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)