Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS

Incision, Surgical Clinical Trial

Official title:

Diathermy Versus Scalpel in the Transverse Abdominal Incision in Primigravida Obese Women Undergoing Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05462418
• Other study ID #: AN2022-7
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: waleed M El-khayat, MD
• Phone: 01005135542
• Email: waleed_elkhyat[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cesarean section is surging worldwide. For an extended period of surgical practice, the scalpel has been well-known as a gold-standard tool for making surgical incisions. The diathermy, electrocautery, is a substitute.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women with BMI 30- 40 Kg/m2.
• Women pregnant with singletons and planned to have a repeat elective lower-segment CS at 38-39 weeks' gestation due to having had one previous CS.
• Women pregnant with singletons and planned to deliver by lower-segment CS at 38-39 weeks' gestation for the first time (primi-section) due to obstetric indication.

Exclusion Criteria:

• Cases with coagulopathies eg. Hemophilia, von Willebrand disease
• Cases on anti-coagulant therapy eg. Heparin, warfarin
• Cases with chronic diseases expected to affect wound healing, such as diabetes, hypertension, liver diseases, chronic anemia, and renal impairment.

Related Conditions & MeSH terms

• Hyperthermia
• Incision, Surgical
• Surgical Wound

Intervention

Procedure:
• electrosurgery
incisions completed using use the unipolar diathermy from Whiteline till we reach the parietal peritoneum (cutting the Whiteline then coagulation till reaching the peritoneum). The used diathermy frequency was 50-70 MHz.
• scalpel
patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.

Locations

Country	Name	City	State
Egypt	faculty of medicine - Cairo university	Cairo	Kasr El Ainy

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss	assess and compare intraoperative blood loss between both studied groups. This was done using visualization technique detecting numbers of fully soaked pads used during the incision.	30 min