Scalpel vs Diathermy in Repeat Cesarean Delivery

Complications; Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493608
• Other study ID #: L15-144
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2020
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complications; Cesarean Section

Intervention

Device:
• scalpel
used to cut the abdominal wall.
• Diathermy
Diathermy used to cut , coagulate the tissue

Locations

Country	Name	City	State
United States	Medical Center Hospital	Odessa	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incision Time .	Time to make an abdominal wall incision from skin to rectus fascia.	during surgery
Secondary	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
Secondary	Blood Loss	Blood lost during incision/surgery	Blood lost during incision/surgery