Scalpel Versus Diathermy Skin Incision in Repeated CS

Not Applicable

Completed

• Conditions: Benifits of Using Diathermy in Skin Incision
• Interventions: Procedure: skin incision with a scalpel; Procedure: skin incision with diathermy

• Registration Number: NCT04818710
• Lead Sponsor: National Research Centre, Egypt

Brief Summary

This study was performed to compare both methods of skin incisions to determine differences in postoperative pain, hemodynamic changes, incisional time, blood loss during incision, wound healing, and wound complication.

Detailed Description

Our study aims to compare the use of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in

1. incision time,

2. incision blood loss,

3. hemodynamic changes,

4. postoperative pain,

5. wound healing

6. wound complications.

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31
• Status Verified: 2021-03
• Study First Submitted: 2021-03-20
• Study First Submitted QC: 2021-03-23
• Last Update Submitted: 2021-03-23
• Study First Posted: 2021-03-26
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 476

Inclusion Criteria

• women with a history of only one previous cesarean section
• age between 18 and 40 years
• gestational age of 38 to 41 weeks
• body mass index less than 30.

Exclusion Criteria

• any medical disorder that can affect wound healing as diabetes, chronic anemia, chronic skin conditions, history of allergy, or history of an infected surgical wound.
• Women who conducted primary or emergency cesarean deliveries
• cardiac patients on pacemakers
• patients on anticoagulants
• women refusing to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
skin incision with a scalpel	skin incision with a scalpel	In the scalpel group, the incision was made by the traditional method, with proper homeostasis by applying pressure to skin blood vessels and ligating the subcutaneous bleeding.
skin incision with diathermy	skin incision with diathermy	In the diathermy group, the incision made using a small flat blade pen electrode, set on cutting mode and delivering a 120 watt (maximum) sinusoidal current, electrosurgical cutting performed without pressure or mechanical displacement.

Primary Outcome Measures

Name	Time	Method
incision time	during surgical operation. the difference between starting skin incision till the rectus sheath was visualized	We compared incisional time by using a digital clock. The incisional time was established as follows: when skin incision was made, the surgeon called out "start the clock". Once the rectus sheath was visualized, the surgeon calls out "stop the clock". The incision time was the difference between "start" and "stop".
incision blood loss	during surgery	This was calculated by weighing the swabs pre and postoperatively (1mg = 1ml) after complete hemostasis was achieved.
postoperative pain	during the first day after surgery	We compared those patients clinically for postoperative pain for 24 hours by visual analog scale (VAS) score, a psychometric response scale, and it is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. It is 11 points numeric scale ranges from "0" representing one pain extreme (e.g., no pain) to "10" representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable"). This score was recorded for each participant at 2,4,6,8,10,12,24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
wound healing	during the first week after surgery	healing by primary versus secondary intention
wound complications	during the first week after surgery	like seroma, hematoma, ecchymosis, dehiscence (separation of the subcutaneous tissues with skin), and infection

Trial Locations

Locations (1)

National Research Centre; 🇪🇬 Cairo, Egypt