NCT01907256

Brief Summary

There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

July 11, 2013

Last Update Submit

January 17, 2014

Conditions

Cosmetic Outcome

Outcome Measures

Primary Outcomes (3)

  • Hollunder cosmetic score

    The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery

    one week after surgery,

  • Hollunder cosmetic score

    The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery

    one month after surgery

  • Hollunder cosmetic score

    The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery

    one year after surgery

Secondary Outcomes (3)

  • Visual analogue score

    one week after surgery,

  • Visual analogue score

    one month after surgery

  • Visual analogue score

    one year after surgery

Study Arms (2)

group A

ACTIVE COMPARATOR

stair step incisions

Procedure: stair step incisions

Group B

ACTIVE COMPARATOR

inverted V incision

Procedure: inverted V incision

Interventions

inverted V incisionPROCEDURE

It is a type of incision

Group B
stair step incisionsPROCEDURE

It is a type of incision

group A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who candidate for open rhinoplasty

You may not qualify if:

  • Revision cases
  • History of scar
  • Systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Tehran Province, 94305, Iran

Location

Study Officials

  • Babak Saaedi

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 24, 2013

Study Start

December 1, 2012

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

IR(1)