NCT03273777

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

2.9 years

First QC Date

June 6, 2017

Last Update Submit

February 22, 2021

Conditions

Cesarean Section

Keywords

Cesarean sectionSkin incisionSkewnessLine drawing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

  • Patient's perception of the scar

    1 minute (before discharge from hospital)

Study Arms (2)

Drawing of an incision line

EXPERIMENTAL

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

Procedure: Drawing of an incision line

No drawing of an incision line

NO INTERVENTION

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

Interventions

Drawing of an incision linePROCEDURE

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

Drawing of an incision line

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥ 18 years
  • First cesarean section

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, Austria

RECRUITING

Central Study Contacts

Heinrich Husslein

CONTACT

0043140400heinrich.husslein@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.-Prof.

Study Record Dates

First Submitted

June 6, 2017

First Posted

September 6, 2017

Study Start

July 1, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)