Ghadeer Abdelazim Mostafa
Banhā, Egypt
NCT Number: NCT06796933
The purpose of the study will be to determine the effect of polarized light therapy (Bioptron) on scar formation after a cesarean section.
Trial opening soon.
Get Notified20 year–30 year
Female
Interventional
Not applicable
Banhā, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participants will be treated with cosmetic creams such as Silicone-based products (silicone gels twice a day) for one month.
The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, for one month.
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
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).
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.
Contact information is provided by the study sponsor or research team.
Amira Nagy, PHD
CONTACT
Ghadeer Mostafa, Master
CONTACT
Cairo University
Other
Effect of Bioptron on Scar Formation After Cesarean Section: a Randomized Controlled Trial
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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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