Cesarean Section; Complications, Wound, DehiscenceNCT07693478
Effect of Bioptron Light Therapy on Wound Healing After Caesarean Section
A study testing Standard Postoperative Medical Care and Bioptron Light Therapy in people with Cesarean Section; Complications, Wound, Dehiscence, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the effect of Bioptron light therapy on wound healing after caesarean section. Read more about this study
- Who is it for?
- Ages 25 to 30 years, women only
- Conditions the study is for
- Cesarean Section; Complications, Wound, Dehiscence
- What is being tested?
- Standard Postoperative Medical Care and Bioptron Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Manal Ahmed El Shafei, PhD contact
Egypt1 site
A specialized surgical hospital in Shebin El-kom
Menouf
Ghada Hamdy Abd Elmoamen, B.Sc, +20 10 60132861, dodoh2034@gmail.com
About this study
The purpose of this study is to investigate the effect of Bioptron light therapy on wound healing after caesarean section.
Read the 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.
- Being tested
- Standard Postoperative Medical Care, Bioptron Light Therapy
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Postoperative Medical CareDrug
Standard postoperative medical care consisting of analgesics, antibiotics, antiseptics, and anti-inflammatory medications prescribed by the treating obstetrician.
Bioptron Light TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard Postoperative Medical Care; Device: Bioptron Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start12 Jul 2026 (estimated)
- Primary completion27 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; Complications, Wound, DehiscenceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Hamdy Abd Elmoamen, Cairo University
- Investigators
- Hala Mohamed Omara, PhD, Study chair, Professor, Cairo UniversityManal Ahmed El Shafei, PhD, Study director, Assist Professor, Cairo UniversitySameh Hussien Samir, PhD, Study director, Professor, National Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693478
- Sponsor's protocol ID
- P.T.REC/012/005904
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bioptron Light Therapy on Wound Healing After Caesarean Section
- ClinicalTrials.gov ID
- NCT07693478
- Acronym / sponsor ID
- P.T.REC/012/005904
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jul 2026 (estimated)
- Primary completion
- 27 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard postoperative medical care | Active comparator | Drug: Standard Postoperative Medical CareParticipants received standard postoperative medical care, including analgesics, antibiotics, antiseptics, and anti-inflammatory medications, as prescribed by the obstetrician, immediately after recovery from anesthesia. |
| Standard postoperative medical care + Bioptron Light Therapy | Experimental | Drug: Standard Postoperative Medical Care, Device: Bioptron Light TherapyParticipants 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. |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Postoperative Medical CareStandard postoperative medical care consisting of analgesics, antibiotics, antiseptics, and anti-inflammatory medications prescribed by the treating obstetrician. | Drug | Standard postoperative medical care, Standard postoperative medical care + Bioptron Light Therapy |
| Bioptron Light TherapyPolarized 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. | Device | Standard postoperative medical care + Bioptron Light Therapy |
Primary outcome
Wound surface area
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.
2 secondary outcomes
Wound healing (REEDA score)
Time frame: 5 days
Wound healing questionnaire (WHQ) score
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Related trials for Cesarean Section; Complications, Wound, Dehiscence
Not yet recruitingObservational study
Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean Section, Surgical Wound Infection
Recruiting
Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions
Cesarean Section, Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manal Ahmed El Shafei, PhD contact
Hala Mohamed Omara, PhD study chair
Professor, Cairo University
Manal Ahmed El Shafei, PhD study director
Assist Professor, Cairo University
Sameh Hussien Samir, PhD study director
Professor, National Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Postoperative Medical Care and Bioptron Light Therapy in people with Cesarean Section; Complications, Wound, Dehiscence, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghada Hamdy Abd Elmoamen, B.Sc (+20 10 60132861, dodoh2034@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound surface area (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.