Effect of Bioptron Light Therapy on Wound Healing After Caesarean Section

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Section; Complications, Wound, Dehiscence
• Intervention / Treatment: Drug: Standard Postoperative Medical Care; Device: Bioptron Light Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ghada Hamdy Abd Elmoamen, B.Sc; Phone Number: +20 10 60132861; Email: dodoh2034@gmail.com
• Study Contact Backup: Name: Manal Ahmed El Shafei, PhD

Study Locations

• Egypt
  • Menouf, Egypt
    • A specialized surgical hospital in Shebin El-kom
    • Contact: Ghada Hamdy Abd Elmoamen, B.Sc; Phone Number: +20 10 60132861; Email: dodoh2034@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard postoperative medical care; Participants received standard postoperative medical care, including analgesics, antibiotics, antiseptics, and anti-inflammatory medications, as prescribed by the obstetrician, immediately after recovery from anesthesia.	Drug: Standard Postoperative Medical Care; Standard postoperative medical care consisting of analgesics, antibiotics, antiseptics, and anti-inflammatory medications prescribed by the treating obstetrician.
Experimental: Standard postoperative medical care + Bioptron Light Therapy; Participants received standard postoperative medical care in addition to Bioptron light therapy (480-3400 nm, energy density 2.4 J/cm², 15 minutes per session, one session daily for 5 consecutive days), initiated within the first 24 hours after cesarean section.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound surface area	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.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing (REEDA score)	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.	5 days
Wound healing questionnaire (WHQ) score	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.	5 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Hala Mohamed Omara, PhD, Professor, Cairo University; Study Director: Manal Ahmed El Shafei, PhD, Assist Professor, Cairo University; Study Director: Sameh Hussien Samir, PhD, Professor, National Research Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 12, 2026
• Primary Completion (Estimated): August 27, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: P.T.REC/012/005904

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No