Cesarean SectionNCT06796933
Effect of Bioptron on Scar Formation After Cesarean Section
A study testing Silicon based products (silicon gel) and Bioptron (polarized light therapy) in people with Cesarean Section, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study will be to determine the effect of polarized light therapy (Bioptron) on scar formation after a cesarean section. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Silicon based products (silicon gel) and Bioptron (polarized light therapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jan 2025to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The participants' ages will be ranged from 20-30 years old.
- Their body mass index (BMI) will not exceed 30 kg/m2.
- They will be primipara and having abdominal scar after CS.
- The scar age will be extended from 6 weeks to 6 months.
- All women will be medically stable when attending the study.
Who cannot join
- Pregnant women or women planning to become pregnant during the study period.
- Women having diabetes mellitus.
- Women taking immunosuppressant drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Bioptron on Scar Formation After Cesarean Section: a Randomized Controlled Trial
The purpose of the study will be to determine the effect of polarized light therapy (Bioptron) on scar formation after a cesarean section.
Read the detailed description
Cesarean deliveries are among the most frequently performed surgical procedures for women worldwide, with their prevalence increasing globally, especially in developing nations like Egypt.
A scar is a natural outcome of the healing process following a wound. Complaints associated with scars can lead to both physical discomfort and psychological challenges. Enhanced healing of CS scars could lead to better postoperative outcomes, reducing complications such as infection, pain, and restricted mobility. These aspects of recovery are often neglected, as noted by.
This study will be the first to specifically examine the effects of Bioptron light therapy on CS scar formation. While previous research has shown the benefits of this therapy on scars from various operations, none have focused on CS scars. By investigating this innovative, non-invasive treatment approach, the study aims to fill a critical gap in existing research and offer valuable insights into managing and improving postoperative recovery for CS patients.
- Conditions
- Cesarean Section
- Being tested
- Silicon based products (silicon gel), Bioptron (polarized light therapy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicon based products (silicon gel)Other
The participants will be treated with cosmetic creams such as Silicone-based products (silicone gels twice a day) for one month.
Bioptron (polarized light therapy)Device
The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, for one month.
| Study group | Role | What they receive |
|---|---|---|
| Silicone-based products group | Active comparator | The participants will be treated with cosmetic creams such as Silicone-based products, (silicone gels for 1 month). Receives: Other: Silicon based products (silicon gel) |
| Bioptron and Silicone-based products group | Experimental | The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, in addition to the cosmetic creams (Silicone-based products; silicone gels) for one month. Receives: Other: Silicon based products (silicon gel); Device: Bioptron (polarized light therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Patient and Observer Scar Assessment Scale (POSAS)
It is a comprehensive tool designed to evaluate scar quality from both the patient's and the observer's perspectives before and after treatment for all participants in both groups. This scale includes two separate assessments: one completed by the patient and the other by the healthcare professional observing the scar. Each part of the scale assesses different aspects of the scar, providing a holistic view of its impact and severity.
Each scale assesses six scar characteristics: the observer evaluates vascularization, pigmentation, thickness, surface roughness, pliability, and surface area, while the patient rates pain, pruritus, color, thickness, relief, and pliability. All items are scored on a 10-point scale, with 1 indicating 'normal skin' and 10 representing the 'worst imaginable scar.' Higher total scores indicate poorer scar quality
Measured: 4 weeks
Vancouver scar scale
The Vancouver Scar Scale (VSS) is a widely used tool for assessing the quality and severity of scars before and after treatment for all participants in both groups. The VSS helps clinicians objectively measure the effectiveness of treatments and track changes in scar characteristics over time The VSS rated the scars according to four parameters: vascularity, pigmentation, pliability, and height. Each parameter contained ranked subscales that may be summed to obtain a total score ranging from 0 (representing normal skin) to 13 (representing the worst scar imaginable).
Measured: 4 weeks
Secondary outcomes (1)
Adheremeter
The modified adheremeter is a plastic sheet with a radius of 4.6 cm, and concentric circles 2 mm apart. It is described as a measurement tool for assessing the extensibility of peripheral surgical scars; it is utilized in evaluating the extensibility of abdominal tissue. Skin mobility at specific points is measured in four directions, and the area of mobility is then calculated. It was reported to have excellent intra-rater reliability when using this method on abdominal tissue.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start27 Jan 2025 (estimated)
- Primary completion18 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghadeer Abdelazzim Mostafa, Cairo University
- Investigators
- Tamer Assar, Professor, Study director, Benha UniversityMohamed Awad, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796933
- Sponsor's protocol ID
- P.T.REC/012/005315
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bioptron on Scar Formation After Cesarean Section: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06796933
- Acronym / sponsor ID
- P.T.REC/012/005315
- Conditions
- Cesarean Section
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Jan 2025 (estimated)
- Primary completion
- 18 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 28 Jan 2025 (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.
The purpose of the study will be to determine the effect of polarized light therapy (Bioptron) on scar formation after a cesarean section.
Detailed description
Cesarean deliveries are among the most frequently performed surgical procedures for women worldwide, with their prevalence increasing globally, especially in developing nations like Egypt.
A scar is a natural outcome of the healing process following a wound. Complaints associated with scars can lead to both physical discomfort and psychological challenges. Enhanced healing of CS scars could lead to better postoperative outcomes, reducing complications such as infection, pain, and restricted mobility. These aspects of recovery are often neglected, as noted by.
This study will be the first to specifically examine the effects of Bioptron light therapy on CS scar formation. While previous research has shown the benefits of this therapy on scars from various operations, none have focused on CS scars. By investigating this innovative, non-invasive treatment approach, the study aims to fill a critical gap in existing research and offer valuable insights into managing and improving postoperative recovery for CS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silicone-based products group | Active comparator | Other: Silicon based products (silicon gel)The participants will be treated with cosmetic creams such as Silicone-based products, (silicone gels for 1 month). |
| Bioptron and Silicone-based products group | Experimental | Other: Silicon based products (silicon gel), Device: Bioptron (polarized light therapy)The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, in addition to the cosmetic creams (Silicone-based products; silicone gels) for one month. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The participants' ages will be ranged from 20-30 years old.
- Their body mass index (BMI) will not exceed 30 kg/m2.
- They will be primipara and having abdominal scar after CS.
- The scar age will be extended from 6 weeks to 6 months.
- All women will be medically stable when attending the study.
Key exclusion criteria (3 listed)
- Pregnant women or women planning to become pregnant during the study period.
- Women having diabetes mellitus.
- Women taking immunosuppressant drugs.
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 |
|---|---|---|
| Silicon based products (silicon gel)The participants will be treated with cosmetic creams such as Silicone-based products (silicone gels twice a day) for one month. | Other | Bioptron and Silicone-based products group, Silicone-based products group |
| Bioptron (polarized light therapy)The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, for one month. | Device | Bioptron and Silicone-based products group |
Primary outcome
The Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 4 weeks
It is a comprehensive tool designed to evaluate scar quality from both the patient's and the observer's perspectives before and after treatment for all participants in both groups. This scale includes two separate assessments: one completed by the patient and the other by the healthcare professional observing the scar. Each part of the scale assesses different aspects of the scar, providing a holistic view of its impact and severity. Each scale assesses six scar characteristics: the observer evaluates vascularization, pigmentation, thickness, surface roughness, pliability, and surface area, while the patient rates pain, pruritus, color, thickness, relief, and pliability. All items are scored on a 10-point scale, with 1 indicating 'normal skin' and 10 representing the 'worst imaginable scar.' Higher total scores indicate poorer scar quality
Vancouver scar scale
Time frame: 4 weeks
The Vancouver Scar Scale (VSS) is a widely used tool for assessing the quality and severity of scars before and after treatment for all participants in both groups. The VSS helps clinicians objectively measure the effectiveness of treatments and track changes in scar characteristics over time The VSS rated the scars according to four parameters: vascularity, pigmentation, pliability, and height. Each parameter contained ranked subscales that may be summed to obtain a total score ranging from 0 (representing normal skin) to 13 (representing the worst scar imaginable).
1 secondary outcome
Adheremeter
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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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.
Tamer Assar, Professor study director
Benha University
Mohamed Awad, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicon based products (silicon gel) and Bioptron (polarized light therapy) in people with Cesarean Section, run by Cairo University at 1 site 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 5 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: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghadeer Mostafa, Master (01093973398, zd94508@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Patient and Observer Scar Assessment Scale (POSAS) (time frame: 4 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 28 Jan 2025.