Scalpel Versus Diathermy Skin Incision in Repeated CS

Comparative Study Between Scalpel and Diathermy Skin Incision in Repeated Cesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Benifits of Using Diathermy in Skin Incision
• Intervention / Treatment: Procedure: skin incision with a scalpel; Procedure: skin incision with diathermy

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 Type: Interventional
• Enrollment (Actual): 476
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • National Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Procedure: skin incision with a scalpel; A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized. group 1 (skin incision with a scalpel)
Active Comparator: 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.	Procedure: skin incision with diathermy; A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized. group 2 (skin incision with diathermy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incision time	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".	during surgical operation. the difference between starting skin incision till the rectus sheath was visualized
incision blood loss	This was calculated by weighing the swabs pre and postoperatively (1mg = 1ml) after complete hemostasis was achieved.	during surgery
postoperative pain	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.	during the first day after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Research Centre, Egypt
• Collaborators: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: March 20, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Surgical Wound; Hyperthermia
• Other Study ID Numbers: diathermy skin incision

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No