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Not yet recruiting NCT07693478

Effect of Bioptron Light Therapy on Wound Healing After Caesarean Section

No phase Interventional Cesarean Section; Complications, Wound, Dehiscence

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: Standard Postoperative Medical Care, Bioptron Light Therapy.
Who it may be relevant to
Registry conditions: Cesarean Section; Complications, Wound, Dehiscence. Basic parameters: 25 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 →

Overview

The purpose of this study is to investigate the effect of Bioptron light therapy on wound healing after caesarean section.

Detailed description

Wound healing process is important after cesarean section without complication and with short period of time; caesarean section (CS) wound complications represent a substantial burden to the health system and the prevention of such complications should be a healthcare priority in developing countries.

Delayed wound healing is when a wound takes longer than normal to heal, it has many hazards such as disruption and fluid collection (hematomas and seromas), adhesions, infection (abscess) and rupture of membranes.

Management and acceleration of wound healing after cesarean section are important for maternal and newborn care and breastfeeding. Many drugs used for this purpose, especially nonsteroidal anti-inflammatory drugs (NSAIDs) and opiates, have side effects including nausea, respiratory distress, gastrointestinal bleeding and itching.

Previous studies indicated using Bioptron light therapy to accelerate wound healing, it can be used as mono therapy. or as complementary therapy for wound healing and treating pain, Also, it can improve microcirculation, harmonize metabolic processes, reinforce the human defense system, stimulate regenerative processes of the entire organism, promote wound healing and relieve pain.

As a non-invasive intervention for wound healing, it enhances the whole individual's regenerative and reparative processes, promote wound healing, regulates vascular endothelial growth factor (VEGF). It also provides faster wound closure, enhanced wound epithelialization and greater scar tensile strength.

To our knowledge, there were few previous studies investigated and confirm the effect of Bioptron light therapy on wound healing in patients with diabetic wound and burn wound.

But until now there is no previous study investigates its effect on post cesarean section wound healing. so, this study will be the first one in this issue. Therefore, the results obtained from this study will be of valuable benefits for medical service organizations and increase body of knowledge of physical therapists in scientific field.

Interventions

  • Drug Standard Postoperative Medical Care
    Standard postoperative medical care consisting of analgesics, antibiotics, antiseptics, and anti-inflammatory medications prescribed by the treating obstetrician.
  • Device Bioptron Light Therapy
    Polarized polychromatic non-coherent light therapy (480-3400 nm, energy density 2.4 J/cm², power density 40 mW/cm², 15 minutes per session, once daily for 5 consecutive days), initiated within the first 24 hours after cesarean section.

Primary outcome measures

  • Wound surface area [Time frame: 5 days]
Secondary outcome measures (2)
  • Wound healing (REEDA score) [Time frame: 5 days]
  • Wound healing questionnaire (WHQ) score [Time frame: 5 days]

Eligibility criteria

Inclusion criteria

  • Post partum women delivered by cesarean section on their first 24 hours after operation.
  • Their ages range from 25 to 30 years old.
  • Their BMI will be less than 30 kg/m2.
  • All females will be clinically diagnosed, confirmed and referred by the obstetricians.
  • They are medically stable.

Exclusion criteria

  • History of any radiotherapy or chemotherapy.
  • History of diabetes.
  • History of psychological problems.
  • Acute infection in area treated.
  • Skin disease or any disease leading to delayed wound healing, such as venous or arterial disease.

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
  • A specialized surgical hospital in Shebin El-kom — Menouf

Identifiers

NCT: NCT07693478 · P.T.REC/012/005904

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗