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Not yet recruiting NCT06796933

Effect of Bioptron on Scar Formation After Cesarean Section

No phase Interventional Cesarean Section

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Silicon based products (silicon gel), Bioptron (polarized light therapy).
Who it may be relevant to
Registry conditions: Cesarean Section. Basic parameters: 20 years — 30 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • The Patient and Observer Scar Assessment Scale (POSAS) [Time frame: 4 weeks]
  • Vancouver scar scale [Time frame: 4 weeks]
Secondary outcome measures (1)
  • Adheremeter [Time frame: 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ghadeer Abdelazim Mostafa — Banhā

Identifiers

NCT: NCT06796933 · P.T.REC/012/005315

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗