Scalpel vs Diathermy in Repeat Cesarean Delivery

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

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

Study Overview

• Status: Completed
• Conditions: Complications; Cesarean Section
• Intervention / Treatment: Device: scalpel; Device: Diathermy

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Odessa, Texas, United States, 79763
      • Medical Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Principal Investigator: Martin Caliendo, M.D, Texas Tech University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia
• Other Study ID Numbers: L15-144