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

NCT ID: NCT05905861

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-12-31

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.

Detailed Description

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.

General 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.

In 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group_A: skin incision with scalpel.

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

Group Type: PLACEBO_COMPARATOR

Skin incision with scalpel.

Intervention Type: 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_B: skin incision with diathermy.

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.

Group Type: ACTIVE_COMPARATOR

Skin incision with a diathermy.

Intervention Type: 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.

Interventions

Skin incision with scalpel.

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.

Intervention Type: PROCEDURE

Skin incision with a diathermy.

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Women without a history of previous cesarean section or other abdominal surgery

2. Age greater then 18 years (only adult patients)

3. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2

4. Gestational age greater then 37 weeks (at term pregnancies)

5. No contraindications to spinal anesthesia

6. Indication to elective CS: extra-obstetrical reasons, failure of medical induction of labor, breech fetal presentation

7. Informed consent

Exclusion Criteria

1. Women refusing to participate in the study

2. Women undergoing urgency or emergency cesarean deliveries

3. Women with a history of previous cesarean section or abdominal surgery

4. Women with multifetal pregnancies

5. Necessity of general anesthesia

6. Use of anticoagulants

7. Patients needing a median longitudinal abdominal section

8. Patients with pacemakers

9. Allergy to cephalosporins

10. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role: lead

Responsible Party

Prof.Amerigo Vitagliano

MD, PhD, Assistant Professor (Researcher type-B)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amerigo Vitagliano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

"Aldo Moro" University of Bari

Locations

Azienda Ospedaliero-Universitaria "Consorziale Policlinico"

Bari, , Italy

Countries

Italy

Central Contacts

Amerigo Vitagliano, MD, PhD

Role: CONTACT

amerigo.vitagliano@gmail.com

0805593321

Amerigo Vitagliano

Role: CONTACT

amerigo.vitagliano@gmail.com

0805593321

Other Identifiers

0049112

Identifier Type: -

Identifier Source: org_study_id