NCT05905861

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

Scalpel Versus Diathermy for Transverse Abdominal Incision in Women Undergoing First Elective Caesarean Section: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2023-06-15
• Last updated: 2023-07-10

Locations

1 site across 1 country: Italy