Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-01-17 @ 11:29 AM
Study NCT ID:
NCT05462418
Status:
UNKNOWN
Last Update Posted:
2022-07-18
First Post:
2022-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D005334', 'term': 'Fever'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004598', 'term': 'Electrosurgery'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2022-07-14', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood loss', 'timeFrame': '30 min', 'description': 'assess and compare intraoperative blood loss between both studied groups. This was done using visualization technique detecting numbers of fully soaked pads used during the incision.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diathermy', 'scalpel', 'cesarean section', 'obese'], 'conditions': ['Incision, Surgical']}, 'descriptionModule': {'briefSummary': 'Cesarean section is surging worldwide. For an extended period of surgical practice, the scalpel has been well-known as a gold-standard tool for making surgical incisions. The diathermy, electrocautery, is a substitute.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women with BMI 30- 40 Kg/m2.\n* Women pregnant with singletons and planned to have a repeat elective lower-segment CS at 38-39 weeks' gestation due to having had one previous CS.\n* Women pregnant with singletons and planned to deliver by lower-segment CS at 38-39 weeks' gestation for the first time (primi-section) due to obstetric indication.\n\nExclusion Criteria:\n\n* Cases with coagulopathies eg. Hemophilia, von Willebrand disease\n* Cases on anti-coagulant therapy eg. Heparin, warfarin\n* Cases with chronic diseases expected to affect wound healing, such as diabetes, hypertension, liver diseases, chronic anemia, and renal impairment."}, 'identificationModule': {'nctId': 'NCT05462418', 'briefTitle': 'Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Diathermy Versus Scalpel in the Transverse Abdominal Incision in Primigravida Obese Women Undergoing Cesarean Section', 'orgStudyIdInfo': {'id': 'AN2022-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'diathermy group', 'description': "Patients' incisions are completed using the unipolar diathermy from Whiteline until we reach the parietal peritoneum (cutting the Whiteline then coagulating until reaching the peritoneum). The used diathermy frequency was 50-70 MHz.", 'interventionNames': ['Procedure: electrosurgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'scalpel', 'description': 'patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.', 'interventionNames': ['Procedure: scalpel']}], 'interventions': [{'name': 'electrosurgery', 'type': 'PROCEDURE', 'otherNames': ['diathermy'], 'description': 'incisions completed using use the unipolar diathermy from Whiteline till we reach the parietal peritoneum (cutting the Whiteline then coagulation till reaching the peritoneum). The used diathermy frequency was 50-70 MHz.', 'armGroupLabels': ['diathermy group']}, {'name': 'scalpel', 'type': 'PROCEDURE', 'description': 'patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.', 'armGroupLabels': ['scalpel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'state': 'Kasr El Ainy', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mohamed T aneis, MD', 'role': 'CONTACT', 'phone': '202 23653269'}, {'name': 'waleed M El khyat, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'faculty of medicine - Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'waleed M El-khayat, MD', 'role': 'CONTACT', 'email': 'waleed_elkhyat@yahoo.com', 'phone': '01005135542'}], 'overallOfficials': [{'name': 'Mohammed A Taymour, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'ahmed nagy shaker ramadan', 'investigatorAffiliation': 'Cairo University'}}}}