Effect of Bioptron on Scar Formation After Cesarean Section

NCT ID: NCT06796933

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-27

Study Completion Date

2025-03-31

Brief Summary

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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

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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

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Silicone-based products group

The participants will be treated with cosmetic creams such as Silicone-based products, (silicone gels for 1 month).

Group Type ACTIVE_COMPARATOR

Silicon based products (silicon gel)

Intervention Type OTHER

The participants will be treated with cosmetic creams such as Silicone-based products (silicone gels twice a day) for one month.

Bioptron and Silicone-based products group

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.

Group Type EXPERIMENTAL

Silicon based products (silicon gel)

Intervention Type 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)

Intervention Type DEVICE

The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, for one month.

Interventions

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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.

Intervention Type OTHER

Bioptron (polarized light therapy)

The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, for one month.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Pregnant women or women planning to become pregnant during the study period.
* Women having diabetes mellitus.
* Women taking immunosuppressant drugs.
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ghadeer Abdelazzim Mostafa

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tamer Assar, Professor

Role: STUDY_DIRECTOR

Benha University

Mohamed Awad, Professor

Role: STUDY_CHAIR

Cairo University

Locations

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Ghadeer Abdelazim Mostafa

Banhā, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ghadeer Mostafa, Master

Role: CONTACT

01093973398

Amira Nagy, PHD

Role: CONTACT

+201021177871

Other Identifiers

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P.T.REC/012/005315

Identifier Type: -

Identifier Source: org_study_id

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