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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Not yet enrolling

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

Treatments: Procedure: Skin incision with a diathermy.; Procedure: Skin incision with scalpel.

Study type: Interventional

Funder types: Other

Identifiers

NCT05905861

0049112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

Group_A: skin incision with scalpel.

Placebo Comparator group

Description:

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

Treatment:

Procedure: Skin incision with scalpel.

Group_B: skin incision with diathermy.

Active Comparator group

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.

Treatment:

Procedure: Skin incision with a diathermy.