Effect of Bioptron Light Therapy on Wound Healing After Caesarean Section

NCT07693478 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005904
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cesarean Section; Complications, Wound, Dehiscence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Wound healing (REEDA score)

  5 days

• Wound healing questionnaire (WHQ) score

  5 days

Study Arms (2)

Standard postoperative medical care

ACTIVE COMPARATOR

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 + Bioptron Light Therapy

EXPERIMENTAL

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; Device: Bioptron Light Therapy

Interventions

Standard Postoperative Medical Care DRUG

Standard postoperative medical care consisting of analgesics, antibiotics, antiseptics, and anti-inflammatory medications prescribed by the treating obstetrician.

Standard postoperative medical care; Standard postoperative medical care + Bioptron Light Therapy

Bioptron Light Therapy DEVICE

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.

Standard postoperative medical care + Bioptron Light Therapy

Eligibility Criteria

• Age: 25 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

A specialized surgical hospital in Shebin El-kom

Menouf, Egypt

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Hala Mohamed Omara, PhD

  Professor, Cairo University

  STUDY CHAIR

• Manal Ahmed El Shafei, PhD

  Assist Professor, Cairo University

  STUDY DIRECTOR

• Sameh Hussien Samir, PhD

  Professor, National Research Center

  STUDY DIRECTOR

Central Study Contacts

Ghada Hamdy Abd Elmoamen, B.Sc

CONTACT

+20 10 60132861; dodoh2034@gmail.com

Manal Ahmed El Shafei, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: July 12, 2026
• Primary Completion (Estimated): August 27, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

EG (1)