Skin Incision Skewness at Cesarean Section

Not Applicable

• Conditions: Cesarean Section
• Interventions: Procedure: Drawing of an incision line

• Registration Number: NCT03273777
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-09-04
• Study First Posted: 2017-09-06
• Study Start: 2018-07-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-23
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• Age ≥ 18 years
• First cesarean section

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Exclusion Criteria

• Performance of an acute cesarean section
• Previous cesarean section
• Body mass index > 35 kg/m²

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drawing of an incision line	Drawing of an incision line	An incision line of 14 cm will be drawn using a conventional surgical ruler and pen before skin incision.

Primary Outcome Measures

Name	Time	Method
Skin incision skewness	10 minutes (from a photograph taken at the end of the operation)	Skewness of the incision will be assessed using digital photos and an appropriate software.

Secondary Outcome Measures

Name	Time	Method
Incision length on both sides of the midline	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)	The length will be measured in cm.
Patient's perception of the scar	1 minute (before discharge from hospital)	Skewness and length of the scar are rated by the patient.

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria