Skin Incision Skewness at Cesarean Section

NCT ID: NCT03273777

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2021-06-30

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.

Conditions

Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Drawing of an incision line

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

Group Type: EXPERIMENTAL

Drawing of an incision line

Intervention Type: PROCEDURE

Drawing of an incision line prior to skin incision at cesarean section

No drawing of an incision line

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Drawing of an incision line

Drawing of an incision line prior to skin incision at cesarean section

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Heinrich Husslein

Ass.-Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Heinrich Husslein

Role: CONTACT

heinrich.husslein@meduniwien.ac.at

0043140400 ext. 28210

Facility Contacts

Heinrich Husslein

Role: primary

Other Identifiers

1641_2016

Identifier Type: -

Identifier Source: org_study_id