NCT02626585

Brief Summary

The purpose of this study was to investigate the effectiveness of postrhinoplasty taping. The effectiveness was evaluated with Ultrasonography and skin envelope thickness was prospectively measured for analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

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

August 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

December 7, 2015

Last Update Submit

December 8, 2015

Conditions

Keywords

rhinoplastypostrhinoplasty tapingedemadrapingpostoperative edemanasal skin thicknesssupratip fullnesspostoperative swelling

Outcome Measures

Primary Outcomes (1)

  • Change in nasal skin thickness (for rhinion, radix, supratip and tip)

    measured with Ultrasonography

    preoperative, postoperative 1st, 3rd and 5th week, postoperative 6th month

Secondary Outcomes (1)

  • Duration of Operation

    Intraoperative

Study Arms (3)

Control

NO INTERVENTION

Control group (n=20): Following removal of nasal cast on postoperative first week, no additional taping was applied to this group.

2-weeks of PRT

EXPERIMENTAL

2-weeks of PRT (n=17): Following removal of nasal cast on postoperative first week, 2 weeks of additional postrhinoplasty taping was applied to this group (form 1st to 3rd week).

Procedure: Postrhinoplasty taping

4-weeks of PRT

EXPERIMENTAL

4-weeks of PRT (n=20): Following removal of nasal cast on postoperative first week, 4 weeks of additional postrhinoplasty taping was applied to this group (form 1st to 5th week).

Procedure: Postrhinoplasty taping

Interventions

Postrhinoplasty taping is commonly applied by rhinoplasty surgeons. Following rhinoplasty the nose is generally taped and a (thermoplastic) nasal cast is applied on top of this to make sure the final form of the nose is protected. Postoperatively, this cast is removed at some point. After this, some of the surgeons prefer to tape the nose with nasal tapes such as Micropore (3M) etc. Postrhinoplasty taping is the term used for this. The nose is (generally) taped horizontally with 1/2 inch wide tapes. This is done superiorly from radix to inferiorly to nasal tip. The idea is to compress the nose and to cover it. The duration of postrhinoplasty taping differs according to the preference of the surgeon and the patient

2-weeks of PRT4-weeks of PRT

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary open approach rhinoplasty under general anesthesia
  • bilateral lateral osteotomies

You may not qualify if:

  • revision cases
  • abnormal haemostatic parameters
  • drug history of decongestant or cortisone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

  • Hafezi F, Naghibzadeh B, Nouhi A. Management of the thick-skinned nose: A more effective approach. Ann Otol Rhinol Laryngol. 2006 Jun;115(6):444-9. doi: 10.1177/000348940611500608.

    PMID: 16805376BACKGROUND
  • Guyuron B, DeLuca L, Lash R. Supratip deformity: a closer look. Plast Reconstr Surg. 2000 Mar;105(3):1140-51; discussion 1152-3. doi: 10.1097/00006534-200003000-00049.

    PMID: 10724276BACKGROUND
  • Rees TD. An aid to the treatment of supratip swelling after rhinoplasty. Laryngoscope. 1971 Feb;81(2):308-11. doi: 10.1288/00005537-197102000-00011. No abstract available.

    PMID: 5544202BACKGROUND
  • Hoefflin SM. Postoperative nighttime nasal taping to decrease swelling. Plast Reconstr Surg. 1989 Aug;84(2):375. doi: 10.1097/00006534-198908000-00057. No abstract available.

    PMID: 2748764BACKGROUND
  • Vega-Villasante P, Covarrubias H. A new splint for the nasal tip. Plast Reconstr Surg. 1995 Jul;96(1):189-93. doi: 10.1097/00006534-199507000-00029.

    PMID: 7604101BACKGROUND
  • Belek KA, Gruber RP. The beneficial effects of postrhinoplasty taping: fact or fiction? Aesthet Surg J. 2014 Jan 1;34(1):56-60. doi: 10.1177/1090820X13515879.

    PMID: 24396072BACKGROUND
  • Ozucer B, Yildirim YS, Veyseller B, Tugrul S, Eren SB, Aksoy F, Uysal O, Ozturan O. Effect of Postrhinoplasty Taping on Postoperative Edema and Nasal Draping: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2016 May 1;18(3):157-63. doi: 10.1001/jamafacial.2015.1944.

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Berke Ozucer, MD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Otorhinolaryngologist

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 10, 2015

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 10, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share

Locations