Effect of Bioptron on Scar Formation After Cesarean Section

Cairo University (CU)

Status: Not yet enrolling

Conditions: Cesarean Section

Treatments: Device: Bioptron (polarized light therapy); Other: Silicon based products (silicon gel)

Study type: Interventional

Funder types: Other

Identifiers

NCT06796933

P.T.REC/012/005315

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Silicone-based products group

Active Comparator group

Description:

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

Treatment:

Other: Silicon based products (silicon gel)

Bioptron and Silicone-based products group

Experimental group

Description:

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.

Treatment:

Other: Silicon based products (silicon gel)

Device: Bioptron (polarized light therapy)