Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section

NCT06352853 | Completed

• 1 other identifier: Diathermy and skin incision cs
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare between using of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in incisional time, incisional blood loss, postoperative pain, wound healing and wound complications.

Conditions

Skin Wound

Keywords

Diathermy-Scalpel-skin incision-Cesarean section

Outcome Measures

Primary Outcomes (2)

• Skin incision time in scalpel versus diathermy group

  The incision time was estimated by using digital clock, time established as follows: when skin incision made, the surgeon called out "start the clock". After opening the rectus sheath, the surgeon called out" stop the clock". Incision time is the difference between "start" and "stop".

  5 months

• Estimation of incision blood loss in both groups

  incision blood loss volume was measured by weighing the swabs pre and postoperatively (1mg = 1ml).

  5 months

Secondary Outcomes (2)

• Postoperative pain in both groups

  5 months

• Postoperative wound healing in both groups

  5 months

Study Arms (2)

Group 1: Scalpel Group

ACTIVE COMPARATOR

A skin incision is made by traditional method, with proper homeostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeding as well as using of diathermy on coagulation mode. Then,the scalpel was used to reach peritoneum.

Other: Skin incision in Cesarean Section by Scalpel

Group 2: Diathermy Group

ACTIVE COMPARATOR

A skin incision is made using a small flat blade pen electrode, set on cutting mode and delivering a 120-wat (maximum) sinusoidal current, electrosurgical cutting performed without pressure or mechanical displacement. Then, we used the scalpel to reach peritoneum.

Other: Skin incision in Cesarean Section by Diathermy

Interventions

Skin incision in Cesarean Section by Diathermy OTHER

Skin incision by diathermy

Group 2: Diathermy Group

Skin incision in Cesarean Section by Scalpel OTHER

Skin incision by scalpel

Group 1: Scalpel Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Elective cesarean section.
• Women with body mass index less than 30.
• Transverse skin incision.

You may not qualify if:

• Women with medical disorder that can affect wound healing as diabetes, hypertension, chronic anemia and with chronic skin conditions as psoriasis and eczema.
• Women with Autoimmune disorders.
• Cardiac patients on pacemakers and patients on anticoagulants.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Shaimaa El Shemy

Giza, Cairo Governorate, 11562, Egypt

Location

Study Officials

• Shaimaa El Shemy, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Obstetrics and Gynecology department

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: April 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 10 years

Locations

EG (1)