Back to resultsScalpel Versus Diathermy Skin Incision in Repeated CS
Primary Purpose
Benifits of Using Diathermy in Skin Incision
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
skin incision with a scalpel
skin incision with diathermy
Sponsored by
About this trial
This is an interventional supportive care trial for Benifits of Using Diathermy in Skin Incision
Eligibility Criteria
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
Sites / Locations
- National Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
skin incision with a scalpel
skin incision with diathermy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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".
incision blood loss
This was calculated by weighing the swabs pre and postoperatively (1mg = 1ml) after complete hemostasis was achieved.
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.
Secondary Outcome Measures
wound healing
healing by primary versus secondary intention
wound complications
like seroma, hematoma, ecchymosis, dehiscence (separation of the subcutaneous tissues with skin), and infection
Full Information
NCT ID
NCT04818710
First Posted
March 20, 2021
Last Updated
March 23, 2021
Sponsor
National Research Centre, Egypt
Collaborators
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04818710
Brief Title
Scalpel Versus Diathermy Skin Incision in Repeated CS
Official Title
Comparative Study Between Scalpel and Diathermy Skin Incision in Repeated Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre, Egypt
Collaborators
Kasr El Aini Hospital
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
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
incision time,
incision blood loss,
hemodynamic changes,
postoperative pain,
wound healing
wound complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benifits of Using Diathermy in Skin Incision
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
476 (Actual)
8. Arms, Groups, and Interventions
Arm Title
skin incision with a scalpel
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
skin incision with diathermy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
skin incision with a scalpel
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
skin incision with diathermy
Intervention Description
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)
Primary Outcome Measure Information:
Title
incision time
Description
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".
Time Frame
during surgical operation. the difference between starting skin incision till the rectus sheath was visualized
Title
incision blood loss
Description
This was calculated by weighing the swabs pre and postoperatively (1mg = 1ml) after complete hemostasis was achieved.
Time Frame
during surgery
Title
postoperative pain
Description
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.
Time Frame
during the first day after surgery
Secondary Outcome Measure Information:
Title
wound healing
Description
healing by primary versus secondary intention
Time Frame
during the first week after surgery
Title
wound complications
Description
like seroma, hematoma, ecchymosis, dehiscence (separation of the subcutaneous tissues with skin), and infection
Time Frame
during the first week after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
National Research Centre
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Scalpel Versus Diathermy Skin Incision in Repeated CS
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