Scalpel Versus Diathermy for Transverse Abdominal Incision in First Elective Caesarean Section

NCT05905861 | Unknown DMC

• 1 other identifier: 0049112
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section; Intraoperative Blood Loss; Postoperative Pain; Wound Heal

Outcome Measures

Primary Outcomes (1)

• Incision blood loss

  This will be calculated by weighing the gauze pre and postoperatively (1mg = 1ml) after complete hemostasis will be achieved.

  During surgery

Secondary Outcomes (5)

• Incision time

  During surgery

• Total surgery time

  During surgery

• Post-operative pain assessed by VAS

  During the first three days after surgery

• Wound complications

  During the first month after surgery

• Cosmetic wound evaluation assessed by POSAS

  One month after surgery

Study Arms (2)

Group_A: skin incision with scalpel.

PLACEBO COMPARATOR

In the scalpel group, the skin incision will be made using the traditional method, with a scalpel (No. 22).

Procedure: Skin incision with scalpel.

Group_B: skin incision with diathermy.

ACTIVE COMPARATOR

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.

Procedure: Skin incision with a diathermy.

Interventions

Skin incision with scalpel. PROCEDURE

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. Group A: skin incision with a scalpel.

Group_A: skin incision with scalpel.

Skin incision with a diathermy. PROCEDURE

A Pfannenstiel skin incision will be made using a scalpel. Subsequently, a diathermy pen electrode will be employed for the dissection of deeper tissues. Optimal hemostasis will be achieved by using the same blade pen electrode, set to coagulation mode. Group B: skin incision with diathermy.

Group_B: skin incision with diathermy.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women without a history of previous cesarean section or other abdominal surgery
• Age greater then 18 years (only adult patients)
• Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
• Gestational age greater then 37 weeks (at term pregnancies)
• No contraindications to spinal anesthesia
• Indication to elective CS: extra-obstetrical reasons, failure of medical induction of labor, breech fetal presentation
• Informed consent

You may not qualify if:

• Women refusing to participate in the study
• Women undergoing urgency or emergency cesarean deliveries
• Women with a history of previous cesarean section or abdominal surgery
• Women with multifetal pregnancies
• Necessity of general anesthesia
• Use of anticoagulants
• Patients needing a median longitudinal abdominal section
• Patients with pacemakers
• Allergy to cephalosporins
• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria "Consorziale Policlinico"

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Amerigo Vitagliano, MD, PhD

  "Aldo Moro" University of Bari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amerigo Vitagliano, MD, PhD

CONTACT

0805593321; amerigo.vitagliano@gmail.com

Amerigo Vitagliano

CONTACT

0805593321; amerigo.vitagliano@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assistant Professor (Researcher type-B)

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: July 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

IT (1)