Scalpel vs Diathermy in Repeat Cesarean Delivery

Study Overview
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Brief Summary
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The objective of this study is to compare scalpel vs. diathermy in abdominal wall incision in pregnant patients undergoing repeat elective cesarean delivery.

Detailed Description
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It is hypothesized that wall incisions made by diathermy compared to scalpel during repeat cesarean delivery will have less incision time, as well as less blood loss. A second hypothesis is that the use of diathermy, compared with scalpel will not increase in post-operative pain. This is a randomized prospective study in women undergoing elective repeat cesarean delivery at Medical Center Hospital in Odessa Texas. Women undergoing cesarean delivery will be randomized into two groups: One group will undergo diathermy to incise the entire abdominal wall ,which includes skin, subcutaneous tissue, rectus muscle until the peritoneal cavity is visible. On the other group scalpel will be used to achieve the same aim. A standardized abdominal wall incision will be made with either diathermy in cut mode or scalpel. Diathermy will be set in a cut mode with standard setting as per surgeons preference. All patients in the study will get standard skin incision in terms of length and depth which will be marked by a ruler. Incision time ( measured in minutes and seconds with stop watch) and amount of bleeding will be measured. Blood loss will be calculated by weighing (in grams) the used lap sponges and comparing this to the weight (in grams0 of fresh lap sponges. Post-operative pain will be measured by a Visual Analogue Scale (VAS). Measurements will be taken at 6:00 to 7:00 AM from post -op day 1 until hospital discharge.

Official Title
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Scalpel vs Diathermy in Making Abdominal Wall Incision During Repeat Cesarean Delivery

Conditions
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Complications; Cesarean Section

Intervention / Treatment
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* Device: scalpel
* Device: Diathermy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiparous pregnant women 18 - 45 years. Gestational ages 37 weeks to 41 weeks, Undergoing repeat elective or repeat emergency cesarean deliveries. Exclusion Criteria: Informed consent can't be obtained in a manner that allows for no impression of undue influence/pressure or sufficient time for patient to consider participation. Primary Cesarean deliveries - as these can bias the selection. Skin conditions such as infections, psoriasis, and eczema.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: scalpel group<br>Scalpel is the device used to make abdominal wall incision in this group of patient. | Device: scalpel<br>* used to cut the abdominal wall.<br>* Other names: Blade;|
| Active Comparator: Diathermy group<br>In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument. | Device: Diathermy<br>* Diathermy used to cut , coagulate the tissue<br>* Other names: Bovie;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision Time . | Time to make an abdominal wall incision from skin to rectus fascia. | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain | Done by VAS scale. Visual Analog Scale to measure pain. Scale range from 0 to 10 with higher values indicating worse pain. | Post Operative Day (POD) 1 and Day 2 | 
| Blood Loss | Blood lost during incision/surgery | Blood lost during incision/surgery |