Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-01 @ 3:58 AM
Study NCT ID:
NCT06796933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-28
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bioptron on Scar Formation After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Patient and Observer Scar Assessment Scale (POSAS)', 'timeFrame': '4 weeks', 'description': "It is a comprehensive tool designed to evaluate scar quality from both the patient's and the observer's perspectives before and after treatment for all participants in both groups. This scale includes two separate assessments: one completed by the patient and the other by the healthcare professional observing the scar. Each part of the scale assesses different aspects of the scar, providing a holistic view of its impact and severity.\n\nEach scale assesses six scar characteristics: the observer evaluates vascularization, pigmentation, thickness, surface roughness, pliability, and surface area, while the patient rates pain, pruritus, color, thickness, relief, and pliability. All items are scored on a 10-point scale, with 1 indicating 'normal skin' and 10 representing the 'worst imaginable scar.' Higher total scores indicate poorer scar quality"}, {'measure': 'Vancouver scar scale', 'timeFrame': '4 weeks', 'description': 'The Vancouver Scar Scale (VSS) is a widely used tool for assessing the quality and severity of scars before and after treatment for all participants in both groups. The VSS helps clinicians objectively measure the effectiveness of treatments and track changes in scar characteristics over time The VSS rated the scars according to four parameters: vascularity, pigmentation, pliability, and height. Each parameter contained ranked subscales that may be summed to obtain a total score ranging from 0 (representing normal skin) to 13 (representing the worst scar imaginable).'}], 'secondaryOutcomes': [{'measure': 'Adheremeter', 'timeFrame': '4 weeks', 'description': 'The modified adheremeter is a plastic sheet with a radius of 4.6 cm, and concentric circles 2 mm apart. It is described as a measurement tool for assessing the extensibility of peripheral surgical scars; it is utilized in evaluating the extensibility of abdominal tissue. Skin mobility at specific points is measured in four directions, and the area of mobility is then calculated. It was reported to have excellent intra-rater reliability when using this method on abdominal tissue.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section']}, 'descriptionModule': {'briefSummary': 'The purpose of the study will be to determine the effect of polarized light therapy (Bioptron) on scar formation after a cesarean section.', 'detailedDescription': 'Cesarean deliveries are among the most frequently performed surgical procedures for women worldwide, with their prevalence increasing globally, especially in developing nations like Egypt.\n\nA scar is a natural outcome of the healing process following a wound. Complaints associated with scars can lead to both physical discomfort and psychological challenges. Enhanced healing of CS scars could lead to better postoperative outcomes, reducing complications such as infection, pain, and restricted mobility. These aspects of recovery are often neglected, as noted by.\n\nThis study will be the first to specifically examine the effects of Bioptron light therapy on CS scar formation. While previous research has shown the benefits of this therapy on scars from various operations, none have focused on CS scars. By investigating this innovative, non-invasive treatment approach, the study aims to fill a critical gap in existing research and offer valuable insights into managing and improving postoperative recovery for CS patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The participants' ages will be ranged from 20-30 years old.\n* Their body mass index (BMI) will not exceed 30 kg/m2.\n* They will be primipara and having abdominal scar after CS.\n* The scar age will be extended from 6 weeks to 6 months.\n* All women will be medically stable when attending the study.\n\nExclusion Criteria:\n\n* Pregnant women or women planning to become pregnant during the study period.\n* Women having diabetes mellitus.\n* Women taking immunosuppressant drugs."}, 'identificationModule': {'nctId': 'NCT06796933', 'briefTitle': 'Effect of Bioptron on Scar Formation After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Bioptron on Scar Formation After Cesarean Section: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Silicone-based products group', 'description': 'The participants will be treated with cosmetic creams such as Silicone-based products, (silicone gels for 1 month).', 'interventionNames': ['Other: Silicon based products (silicon gel)']}, {'type': 'EXPERIMENTAL', 'label': 'Bioptron and Silicone-based products group', 'description': 'The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, in addition to the cosmetic creams (Silicone-based products; silicone gels) for one month.', 'interventionNames': ['Other: Silicon based products (silicon gel)', 'Device: Bioptron (polarized light therapy)']}], 'interventions': [{'name': 'Silicon based products (silicon gel)', 'type': 'OTHER', 'description': 'The participants will be treated with cosmetic creams such as Silicone-based products (silicone gels twice a day) for one month.', 'armGroupLabels': ['Bioptron and Silicone-based products group', 'Silicone-based products group']}, {'name': 'Bioptron (polarized light therapy)', 'type': 'DEVICE', 'description': 'The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, for one month.', 'armGroupLabels': ['Bioptron and Silicone-based products group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banhā', 'country': 'Egypt', 'facility': 'Ghadeer Abdelazim Mostafa', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'Ghadeer Mostafa, Master', 'role': 'CONTACT', 'email': 'zd94508@gmail.com', 'phone': '01093973398'}, {'name': 'Amira Nagy, PHD', 'role': 'CONTACT', 'email': 'dr.Amira.Nagy@cu.edu.eg', 'phone': '+201021177871'}], 'overallOfficials': [{'name': 'Tamer Assar, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Benha University'}, {'name': 'Mohamed Awad, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ghadeer Abdelazzim Mostafa', 'investigatorAffiliation': 'Cairo University'}}}}