Skin Incision Skewness at Cesarean Section

Cesarean Section Clinical Trial

Official title:

Comparison of Skin Incision Skewness With or Without Previous Measurement and Drawing of the Incision Line at Cesarean Section - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03273777
• Other study ID #: 1641_2016
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 2021

Study information

• Verified date: February 2021
• Source: Medical University of Vienna
• Contact: Heinrich Husslein
• Phone: 0043140400
• Email: heinrich.husslein[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Skin incision skewness, incision length on both sides of the midline and patient's perception of the scar after cesarean section will be compared between the following two groups: (1) Drawing of an incision line prior to skin incision and (2) no drawing of an incision line.

Description:

Some aspects of the surgical techniques employed during cesarean section have already been evaluated in regards to possible improvements of cosmetic outcome, such as the use of different skin closure materials or whether subcutaneous fat suture closure leads to better results than non-closure. Another point to be considered is the skewness of the scar. Many surgeons make the skin incision based on their experience without prior measurement and drawing of an incision line. However, following a predefined incision line may reduce the rate of skew incisions. Therefore, this study aims to compare these two approaches to the skin incision.

Participating women will be recruited at the Department of Obstetrics and Gynecology of the Medical University of Vienna. They will be included into the study after written informed consent and will be randomized into one of the two groups (drawing of an incision line prior to skin incision versus no drawing of an incision line) on the day of cesarean section.

Skewness of the skin incision in each group will be assessed after cesarean section. Furthermore, it will be determined whether there are any differences in the incision length on both sides of an imaginary line from the umbilicus to the clitoris between these two techniques. Additionally, patient's perception of the scar before discharge from hospital will be assessed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age = 18 years

• First cesarean section

Exclusion Criteria:

• Performance of an acute cesarean section

• Previous cesarean section

• Body mass index > 35 kg/m²

Related Conditions & MeSH terms

• Cesarean Section
• Surgical Wound

Intervention

Procedure:
• Drawing of an incision line
Drawing of an incision line prior to skin incision at cesarean section

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin incision skewness	Skewness of the incision will be assessed using digital photos and an appropriate software.	10 minutes (from a photograph taken at the end of the operation)
Secondary	Incision length on both sides of the midline	The length will be measured in cm.	2 minutes (1 minute for measurement at the end of the operation and 1 minute postoperatively from a photo taken at the end of the operation)
Secondary	Patient's perception of the scar	Skewness and length of the scar are rated by the patient.	1 minute (before discharge from hospital)