A specialized surgical hospital in Shebin El-kom
Menouf, Egypt
NCT Number: NCT07693478
The purpose of this study is to investigate the effect of Bioptron light therapy on wound healing after caesarean section.
Trial opening soon.
Get Notified25 year–30 year
Female
Interventional
Not applicable
Menouf, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard postoperative medical care consisting of analgesics, antibiotics, antiseptics, and anti-inflammatory medications prescribed by the treating obstetrician.
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.
Time frame: 5 days
The wound surface area (cm²) will be measured by ultrasonography using the wound length × width method. Ultrasound imaging will be performed using a 2.8-10 MHz transducer to objectively assess wound healing. A reduction in wound surface area indicates improved wound healing.
Time frame: 5 days
Wound healing will be evaluated using the REEDA scale, which assesses five clinical parameters: Redness, Edema, Ecchymosis, Discharge, and Approximation. Each parameter is scored from 0 to 3, yielding a total score ranging from 0 to 15, with lower scores indicating better wound healing.
Time frame: 5 days
Wound healing will be assessed using the validated Bluebelle Wound Healing Questionnaire (WHQ), which evaluates wound-related signs, symptoms, and wound care interventions following abdominal surgery. Higher total scores indicate greater wound-related problems and delayed healing.
Contact information is provided by the study sponsor or research team.
Ghada Hamdy Abd Elmoamen, B.Sc
CONTACT
Manal Ahmed El Shafei, PhD
CONTACT
Cairo University
Other
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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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