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Scalpel vs Diathermy in Repeat Cesarean Delivery

Primary Purpose

Complications; Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
scalpel
Diathermy
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complications; Cesarean Section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Medical Center Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

scalpel group

Diathermy group

Arm Description

Scalpel is the device used to make abdominal wall incision in this group of patient.

In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.

Outcomes

Primary Outcome Measures

Incision Time .
Time to make an abdominal wall incision from skin to rectus fascia.

Secondary Outcome Measures

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.
Blood Loss
Blood lost during incision/surgery

Full Information

First Posted
July 6, 2015
Last Updated
March 10, 2020
Sponsor
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT02493608
Brief Title
Scalpel vs Diathermy in Repeat Cesarean Delivery
Official Title
Scalpel vs Diathermy in Making Abdominal Wall Incision During Repeat Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Cesarean Section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
scalpel group
Arm Type
Active Comparator
Arm Description
Scalpel is the device used to make abdominal wall incision in this group of patient.
Arm Title
Diathermy group
Arm Type
Active Comparator
Arm Description
In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.
Intervention Type
Device
Intervention Name(s)
scalpel
Other Intervention Name(s)
Blade
Intervention Description
used to cut the abdominal wall.
Intervention Type
Device
Intervention Name(s)
Diathermy
Other Intervention Name(s)
Bovie
Intervention Description
Diathermy used to cut , coagulate the tissue
Primary Outcome Measure Information:
Title
Incision Time .
Description
Time to make an abdominal wall incision from skin to rectus fascia.
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
Post Operative Pain
Description
Done by VAS scale. Visual Analog Scale to measure pain. Scale range from 0 to 10 with higher values indicating worse pain.
Time Frame
Post Operative Day (POD) 1 and Day 2
Title
Blood Loss
Description
Blood lost during incision/surgery
Time Frame
Blood lost during incision/surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Caliendo, M.D
Organizational Affiliation
Texas Tech University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center Hospital
City
Odessa
State/Province
Texas
ZIP/Postal Code
79763
Country
United States

12. IPD Sharing Statement

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Scalpel vs Diathermy in Repeat Cesarean Delivery

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