Scalpel Versus Diathermy Skin Incision in Repeated CS

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Benifits of Using Diathermy in Skin Incision

Intervention / Treatment
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* Procedure: skin incision with a scalpel
* Procedure: skin incision with diathermy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: skin incision with a scalpel<br>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<br>* 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)<br>|
| Active Comparator: skin incision with diathermy<br>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<br>* 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)<br>|

What is the study measuring?
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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 |