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Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS

Primary Purpose

Incision, Surgical

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
electrosurgery
scalpel
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Incision, Surgical focused on measuring Diathermy, scalpel, cesarean section, obese

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • faculty of medicine - Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

diathermy group

scalpel

Arm 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.

patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2022
Last Updated
July 14, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05462418
Brief Title
Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS
Official Title
Diathermy Versus Scalpel in the Transverse Abdominal Incision in Primigravida Obese Women Undergoing Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
February 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incision, Surgical
Keywords
Diathermy, scalpel, cesarean section, obese

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
diathermy group
Arm Type
Active Comparator
Arm 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.
Arm Title
scalpel
Arm Type
Active Comparator
Arm Description
patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.
Intervention Type
Procedure
Intervention Name(s)
electrosurgery
Other Intervention Name(s)
diathermy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
scalpel
Intervention Description
patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.
Primary Outcome Measure Information:
Title
blood loss
Description
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.
Time Frame
30 min

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
waleed M El-khayat, MD
Phone
01005135542
Email
waleed_elkhyat@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Taymour, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
faculty of medicine - Cairo university
City
Cairo
State/Province
Kasr El Ainy
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed T aneis, MD
Phone
202 23653269
First Name & Middle Initial & Last Name & Degree
waleed M El khyat, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS

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