Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-27 @ 10:04 PM
Study NCT ID:
NCT05905861
Status:
UNKNOWN
Last Update Posted:
2023-07-10
First Post:
2023-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scalpel Versus Diathermy for Transverse Abdominal Incision in First Elective Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, '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': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-07', 'studyFirstSubmitDate': '2023-06-07', 'studyFirstSubmitQcDate': '2023-06-07', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incision blood loss', 'timeFrame': 'During surgery', 'description': 'This will be calculated by weighing the gauze pre and postoperatively (1mg = 1ml) after complete hemostasis will be achieved.'}], 'secondaryOutcomes': [{'measure': 'Incision time', 'timeFrame': 'During surgery', 'description': 'We will compare incisional time by using a digital clock. The incisional time will be established as follows: when skin incision will be made, the surgeon will verbally announce "start ". Once the parietal peritoneum will be opened, the surgeon will announce "stop". The incision time will be calculated as the difference between "start" and "stop" times.'}, {'measure': 'Total surgery time', 'timeFrame': 'During surgery', 'description': 'Total surgery time will be the time between the start of the skin incision and the completion of the skin suture.'}, {'measure': 'Post-operative pain assessed by VAS', 'timeFrame': 'During the first three days after surgery', 'description': "Post-operative pain will be evaluated for each participant at 1, 4, 8, 16, 24, 48, 72 hours postoperatively, by using the Visual Analog Scale (VAS). The VAS consists of a 10 cm long horizontal line with its extremes marked as 'no pain' (0) and 'worst pain imaginable' (10)."}, {'measure': 'Wound complications', 'timeFrame': 'During the first month after surgery', 'description': 'Will include edema, seroma, hematoma, dehiscence, and infection. The wound will be evaluated 24h and 72h after surgery, before patients discharge. Then, outpatient wound evaluation will be made 7 and 30 days after surgery.'}, {'measure': 'Cosmetic wound evaluation assessed by POSAS', 'timeFrame': 'One month after surgery', 'description': 'The cosmetic aspect of the wound will be evaluated outpatient 30 days after surgery by using the Patient and Observer Scar Assessment Scale (POSAS), that is a questionnaire that was developed to assess scar quality. It consists of two separate six-item scales (Observer Scale and Patient Scale), both of which are scored on a 10-point rating scale (1 = best result; 10 = worst result).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section', 'Intraoperative Blood Loss', 'Postoperative Pain', 'Wound Heal']}, 'descriptionModule': {'briefSummary': 'The objective of this study will be to compare two methods of skin incisions during the first caesarean section (CS), that is scalpel and diathermy, assessing differences in blood loss during incision, incisional time, total surgery time, post-operative pain, wound healing, complications, and cosmetic outcomes.', 'detailedDescription': 'The scalpel has been historically used as the primary cutting tool during caesarean section (CS). However, advancements in surgical devices have introduced alternatives, such as the option to make a diathermic cut using electrosurgical units.\n\nGeneral surgeons have extensively demonstrated the advantages of diathermy over the scalpel for abdominal wall incisions, including faster opening time, reduced incisional blood loss, decreased post-operative pain, and a comparable wound complication rate.\n\nIn obstetrics, there is a scarcity of evidence in this regard, and no consensus or guidelines have been established regarding the optimal method for making a transverse abdominal incision during the first elective CS. Currently, the choice between using a scalpel or diathermy remains at discretion of the obstetric surgeon. The objective of this study will be to compare both methods of skin incisions during the first CS, assessing differences in blood loss during incision, incisional time, total surgery time, post-operative pain, wound healing, complications, and cosmetic outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women without a history of previous cesarean section or other abdominal surgery\n2. Age greater then 18 years (only adult patients)\n3. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2\n4. Gestational age greater then 37 weeks (at term pregnancies)\n5. No contraindications to spinal anesthesia\n6. Indication to elective CS: extra-obstetrical reasons, failure of medical induction of labor, breech fetal presentation\n7. Informed consent\n\nExclusion Criteria:\n\n1. Women refusing to participate in the study\n2. Women undergoing urgency or emergency cesarean deliveries\n3. Women with a history of previous cesarean section or abdominal surgery\n4. Women with multifetal pregnancies\n5. Necessity of general anesthesia\n6. Use of anticoagulants\n7. Patients needing a median longitudinal abdominal section\n8. Patients with pacemakers\n9. Allergy to cephalosporins\n10. Any medical disorder that can affect wound healing as diabetes, hypertension, hepatic or renal diseases, chronic anemia, chronic skin conditions, congenital or acquired bleeding diathesis.'}, 'identificationModule': {'nctId': 'NCT05905861', 'briefTitle': 'Scalpel Versus Diathermy for Transverse Abdominal Incision in First Elective Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari'}, 'officialTitle': 'Scalpel Versus Diathermy for Transverse Abdominal Incision in Women Undergoing First Elective Caesarean Section: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0049112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group_A: skin incision with scalpel.', 'description': 'In the scalpel group, the skin incision will be made using the traditional method, with a scalpel (No. 22).', 'interventionNames': ['Procedure: Skin incision with scalpel.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group_B: skin incision with diathermy.', 'description': 'In the diathermy group, the incision will be made using a small flat blade pen electrode without applying pressure. The electrode will be set to cutting mode, delivering a sinusoidal current of maximum 120 watts.', 'interventionNames': ['Procedure: Skin incision with a diathermy.']}], 'interventions': [{'name': 'Skin incision with scalpel.', 'type': 'PROCEDURE', 'description': 'A Pfannenstiel skin incision will be performed using a scalpel, extending through the subcutaneous tissue and rectus sheath. After separation of rectus muscles, peritoneum will be visualized and opened. Optimal hemostasis will be achieved by applying pressure to skin blood vessels and ligating any subcutaneous bleeding.\n\nGroup A: skin incision with a scalpel.', 'armGroupLabels': ['Group_A: skin incision with scalpel.']}, {'name': 'Skin incision with a diathermy.', 'type': 'PROCEDURE', 'description': 'A Pfannenstiel skin incision will be made using a scalpel. Subsequently, a diathermy pen electrode will be employed for the dissection of deeper tissues.\n\nOptimal hemostasis will be achieved by using the same blade pen electrode, set to coagulation mode.\n\nGroup B: skin incision with diathermy.', 'armGroupLabels': ['Group_B: skin incision with diathermy.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria "Consorziale Policlinico"', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'centralContacts': [{'name': 'Amerigo Vitagliano, MD, PhD', 'role': 'CONTACT', 'email': 'amerigo.vitagliano@gmail.com', 'phone': '0805593321'}, {'name': 'Amerigo Vitagliano', 'role': 'CONTACT', 'email': 'amerigo.vitagliano@gmail.com', 'phone': '0805593321'}], 'overallOfficials': [{'name': 'Amerigo Vitagliano, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Aldo Moro" University of Bari'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Assistant Professor (Researcher type-B)', 'investigatorFullName': 'Prof.Amerigo Vitagliano', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari'}}}}