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NCT Number: NCT06796933

Effect of Bioptron on Scar Formation After Cesarean Section

The purpose of the study will be to determine the effect of polarized light therapy (Bioptron) on scar formation after a cesarean section.

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Key information

Conditions

Age range

20 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ghadeer Abdelazim Mostafa

Banhā, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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).

Secondary outcomes

  1. Adheremeter

    Time frame: 4 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira Nagy, PHD

CONTACT

[email protected]

+201021177871

Ghadeer Mostafa, Master

CONTACT

[email protected]

01093973398

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Bioptron on Scar Formation After Cesarean Section: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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