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Skin Incision Skewness at Cesarean Section

Primary Purpose

Cesarean Section

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Drawing of an incision line
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section focused on measuring Cesarean section, Skin incision, Skewness, Line drawing

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Drawing of an incision line

No drawing of an incision line

Arm Description

An incision line of 14 cm will be drawn using a conventional surgical ruler and pen before skin incision.

Skin incision will be carried out without previous drawing of an incision line.

Outcomes

Primary Outcome Measures

Skin incision skewness
Skewness of the incision will be assessed using digital photos and an appropriate software.

Secondary Outcome Measures

Incision length on both sides of the midline
The length will be measured in cm.
Patient's perception of the scar
Skewness and length of the scar are rated by the patient.

Full Information

First Posted
June 6, 2017
Last Updated
February 22, 2021
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03273777
Brief Title
Skin Incision Skewness at Cesarean Section
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section
Keywords
Cesarean section, Skin incision, Skewness, Line drawing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drawing of an incision line
Arm Type
Experimental
Arm Description
An incision line of 14 cm will be drawn using a conventional surgical ruler and pen before skin incision.
Arm Title
No drawing of an incision line
Arm Type
No Intervention
Arm Description
Skin incision will be carried out without previous drawing of an incision line.
Intervention Type
Procedure
Intervention Name(s)
Drawing of an incision line
Intervention Description
Drawing of an incision line prior to skin incision at cesarean section
Primary Outcome Measure Information:
Title
Skin incision skewness
Description
Skewness of the incision will be assessed using digital photos and an appropriate software.
Time Frame
10 minutes (from a photograph taken at the end of the operation)
Secondary Outcome Measure Information:
Title
Incision length on both sides of the midline
Description
The length will be measured in cm.
Time Frame
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)
Title
Patient's perception of the scar
Description
Skewness and length of the scar are rated by the patient.
Time Frame
1 minute (before discharge from hospital)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heinrich Husslein
Phone
0043140400
Ext
28210
Email
heinrich.husslein@meduniwien.ac.at
Facility Information:
Facility Name
Medical University Vienna
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heinrich Husslein

12. IPD Sharing Statement

Plan to Share IPD
No

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Skin Incision Skewness at Cesarean Section

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