Scar; Previous Cesarean SectionNCT06658444
Effect of Onion Extract Nanoparticle Gel Phonophoresis on Postsurgical Scar of Cesarean Section.
A study testing Phonophoresis in people with Scar; Previous Cesarean Section, run by October 6 University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Scar; Previous Cesarean Section
- What is being tested?
- Phonophoresis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 12 Sep 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Heba
Cairo
Heba ahmed, doctoral, 01117671712, Heba.Ahmed.PT@o6u.edu.eg
- Recruiting
Heba
Cairo
menna abbass, 01202299885, mennaabbass.pt@o6u.edu.eg
About this study
Official title: 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
Read the 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
- Conditions
- Scar; Previous Cesarean Section
- Being tested
- Phonophoresis, sham ultrasound
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhonophoresisOther
Pulsed ultrasound will be used at a frequency of 1 MHz with an intensity of 0.5 W/ cm2 for 5 minutes.
sham ultrasoundOther
sham ultrasound
| Study group | Role | What they receive |
|---|---|---|
| phonophoresis group | Experimental | Twenty women will receive onion extract phonophoresis (3 sessions/week) for 12 weeks in addition to deep friction massage. Receives: Other: Phonophoresis |
| control group | Sham comparator | Twenty women will receive sham ultrasound (3 sessions/week) for 12 weeks in addition to deep friction massage. Receives: Other: sham ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start12 Sep 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar; Previous Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba Haridy, October 6 University
- Investigators
- Heba Haridy, doctoral, Principal investigator, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658444
- Sponsor's protocol ID
- 000114
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Onion Extract Nanoparticle Gel Phonophoresis on Postsurgical Scar of Cesarean Section
- ClinicalTrials.gov ID
- NCT06658444
- Acronym / sponsor ID
- 000114
- Conditions
- Scar; Previous Cesarean Section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| phonophoresis group | Experimental | Other: PhonophoresisTwenty women will receive onion extract phonophoresis (3 sessions/week) for 12 weeks in addition to deep friction massage. |
| control group | Sham comparator | Other: sham ultrasoundTwenty women will receive sham ultrasound (3 sessions/week) for 12 weeks in addition to deep friction massage. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhonophoresisPulsed ultrasound will be used at a frequency of 1 MHz with an intensity of 0.5 W/ cm2 for 5 minutes. | Other | phonophoresis group |
| sham ultrasoundsham ultrasound | Other | control group |
Primary outcome
Modified Vancouver scar scale
Time frame: 12 weeks
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)
Tonometer
Time frame: 12 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Scar; Previous Cesarean Section
Active, not recruiting
Comparison of Purse String Suture vs Transverse Mattress Suture to Maintain Hemostasis in Thinned-out Caesarean Sections Scars
Thinned-out Lower Uterine Segment Scar Previous Cesarean Section
RecruitingObservational study
Relation Between Type of Scar Pregnancy and Number of Previous Cesarean Sections
Scar Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba Haridy, doctoral principal investigator
Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonophoresis in people with Scar; Previous Cesarean Section, run by October 6 University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba Haridy, doctoral (01117671712, Heba.Ahmed.PT@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Vancouver scar scale (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.