Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2015-07-31
2017-06-30
Brief Summary
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Detailed Description
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1. This is a randomized prospective study in women undergoing elective repeat cesarean delivery at Medical Center Hospital in Odessa Texas.
2. 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.
3. 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.
4. 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.
5. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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scalpel group
Scalpel is the device used to make abdominal wall incision in this group of patient.
scalpel
used to cut the abdominal wall.
Diathermy group
In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.
Diathermy
Diathermy used to cut , coagulate the tissue
Interventions
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scalpel
used to cut the abdominal wall.
Diathermy
Diathermy used to cut , coagulate the tissue
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gestational ages 37 weeks to 41 weeks,
* Undergoing repeat elective or repeat emergency cesarean deliveries.
Exclusion Criteria
* Primary Cesarean deliveries - as these can bias the selection.
* Skin conditions such as infections, psoriasis, and eczema.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Texas Tech University Health Sciences Center
OTHER
Responsible Party
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Principal Investigators
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Martin Caliendo, M.D
Role: PRINCIPAL_INVESTIGATOR
Texas Tech University
Locations
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Medical Center Hospital
Odessa, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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L15-144
Identifier Type: -
Identifier Source: org_study_id
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