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Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS

Cairo University (CU) logo

Cairo University (CU)

Status

Enrolling

Conditions

Incision, Surgical

Treatments

Procedure: scalpel
Procedure: electrosurgery

Study type

Interventional

Funder types

Other

Identifiers

NCT05462418
AN2022-7

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 2 patient groups

diathermy group
Active Comparator group
Description:
Patients' incisions are completed using the unipolar diathermy from Whiteline until we reach the parietal peritoneum (cutting the Whiteline then coagulating until reaching the peritoneum). The used diathermy frequency was 50-70 MHz.
Treatment:
Procedure: electrosurgery
scalpel
Active Comparator group
Description:
patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.
Treatment:
Procedure: scalpel

Trial contacts and locations

1

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Central trial contact

waleed M El-khayat, MD

Data sourced from clinicaltrials.gov

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