Clinical trial NCT05905861: Scalpel Versus Diathermy for Transverse Abdominal Incision in First Elective Caesarean Section
Official title: Scalpel Versus Diathermy for Transverse Abdominal Incision in Women Undergoing First Elective Caesarean Section: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Section
Intraoperative Blood Loss
Postoperative Pain
Wound Heal
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Incision blood loss
timeFrame: During surgery
Secondary outcomes:
measure: Incision time
timeFrame: During surgery
measure: Total surgery time
timeFrame: During surgery
measure: Post-operative pain assessed by VAS
timeFrame: During the first three days after surgery
measure: Wound complications
timeFrame: During the first month after surgery
measure: Cosmetic wound evaluation assessed by POSAS
timeFrame: One month after surgery
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria "Consorziale Policlinico"
Study officials:
affiliation: "Aldo Moro" University of Bari
name: Amerigo Vitagliano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: