search
Back to results

The Effect of Postrhinoplasty Taping on Postoperative Edema and Nasal Draping (PRT)

Primary Purpose

Nasal Deformity, Edema, Rhinoplasty

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Postrhinoplasty taping
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Deformity focused on measuring rhinoplasty, postrhinoplasty taping, edema, draping, postoperative edema, nasal skin thickness, supratip fullness, postoperative swelling

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Bezmialem Vakıf University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

2-weeks of PRT

4-weeks of PRT

Arm Description

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 (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).

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).

Outcomes

Primary Outcome Measures

Change in nasal skin thickness (for rhinion, radix, supratip and tip)
measured with Ultrasonography

Secondary Outcome Measures

Duration of Operation
(minutes)(incision to closure duration)

Full Information

First Posted
December 7, 2015
Last Updated
December 8, 2015
Sponsor
Bezmialem Vakif University
search

1. Study Identification

Unique Protocol Identification Number
NCT02626585
Brief Title
The Effect of Postrhinoplasty Taping on Postoperative Edema and Nasal Draping
Acronym
PRT
Official Title
The Effect of Postrhinoplasty Taping on Postoperative Edema and Nasal Draping
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
All patients were informed individually about the procedures and written informed consent was obtained before the study. Undergoing primary open approach reduction rhinoplasty and receiving osteotomies with lateral guarded osteotomes was an inclusion criteria for the study. Fifty-seven consecutive primary open approach rhinoplasty patients that referred to our tertiary reference center were enrolled in the study. Patients were appointed to either the control, 2-week PRT or 4-week PRT group in a randomized-consecutive fashion. External thermoplastic splint was removed at the end of first postoperative week. Patients in the control group were not subjected to further nasal taping after cast removal. All patients in 2-week (from first to third week) and 4-week (from first to fifth week) PRT groups received taping during their allocated time in addition to one week with external nasal splint. These two groups were provided with 1/2-inch wide tan-colored hypoallergenic 3M™ Micropore™ Surgical Tapes (3M, St Paul, Minnesota). Each volunteer was individually shown how and given instructions regarding PRT. Nasal swelling of the patients were evaluated individually with a 7.5 mHz linear ultrasound (US) probe: small amount of ultrasonic gel was used to scan the skin in a noncontact mode to prevent distortion of nasal anatomy from transducer pressure. The examiner did not have access to the results of the previously obtained measurements in order to prevent measurements from being contaminated. Measurements were carried out on four different points: nasion, rhinion, supratip and tip and from these four measurements, mean nasal skin thickness (MNST) was calculated. Subjects in each group were sorted, based on the baseline MNST measurement, consecutively from lowest to highest; half of the patients with higher MNST measurements were categorized as 'thick skinned' and the other half was categorized as 'thin skinned'. The electronic caliper of the machine measured the perpendicular distance from the outer epidermal surface to the underlying cartilage on the 2-dimensional B-mode image (Capasee II Ultrasound, Toshiba Medical Systems, Tustin, California). US measurements were carried out five times for each individual subject: preoperatively; at the end of first, third and fifth postoperative weeks; and sixth postoperative month. Measurements were carried out mainly in the morning to avoid the effect of diurnal variation on the dermal edema. Surgical Technique All of the patients were operated with open approach rhinoplasty under general anesthesia. All patients underwent rhinoplasty due to cosmetic and functional purposes. All cases were distributed evenly between the surgeons (BO, YSY, BV, ST). Supraperichondrial and subperiosteal dissection plane was the preferred plane of dissection in all the cases. Surgical operation was mainly reduction rhinoplasty and comprised of dorsal reduction and bilateral lateral osteotomies. All lateral osteotomies were carried out intranasally with guarded curved lateral osteotomes. Incision-to-closure operative duration was recorded for each patient. All subjects were routinely administered 0.1mg/kg dexamethasone during the operation. All cases were applied with internal splints, taped with 3M micropores and casted with external thermoplastic splints at the end of the operation. Postoperative suggestions, orders and medications were identical for all groups. Patients were discharged from the hospital on first postoperative day. All subjects were called back on the end of first postoperative week for removal of external nasal packing. Statistical Analysis Statistical data were analysed using SPSS 20.0 (SPSS, Chicago,IL). All values were calculated and stated in descriptive statistics as mean±Standard deviation unless otherwise stated. ANOVA was used for comparison of means. Repeated ANOVA was used for each patient where the repeated factor was the ultrasonographic measurements (preoperative, first postoperative week, third postoperative week, fifth postoperative week and sixth postoperative month). Significant results of repeated ANOVA test were further analysed via pairwise comparison with Bonferroni correction. Correlation analysis was carried out with Pearson correlation analysis. Values of p<0.05 were considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Deformity, Edema, Rhinoplasty
Keywords
rhinoplasty, postrhinoplasty taping, edema, draping, postoperative edema, nasal skin thickness, supratip fullness, postoperative swelling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group (n=20): Following removal of nasal cast on postoperative first week, no additional taping was applied to this group.
Arm Title
2-weeks of PRT
Arm Type
Experimental
Arm Description
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).
Arm Title
4-weeks of PRT
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Postrhinoplasty taping
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in nasal skin thickness (for rhinion, radix, supratip and tip)
Description
measured with Ultrasonography
Time Frame
preoperative, postoperative 1st, 3rd and 5th week, postoperative 6th month
Secondary Outcome Measure Information:
Title
Duration of Operation
Description
(minutes)(incision to closure duration)
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary open approach rhinoplasty under general anesthesia bilateral lateral osteotomies Exclusion Criteria: revision cases abnormal haemostatic parameters drug history of decongestant or cortisone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berke Ozucer, MD
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16805376
Citation
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.
Results Reference
background
PubMed Identifier
10724276
Citation
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.
Results Reference
background
PubMed Identifier
5544202
Citation
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.
Results Reference
background
PubMed Identifier
2748764
Citation
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.
Results Reference
background
PubMed Identifier
7604101
Citation
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.
Results Reference
background
PubMed Identifier
24396072
Citation
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.
Results Reference
background
PubMed Identifier
26914594
Citation
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.
Results Reference
derived

Learn more about this trial

The Effect of Postrhinoplasty Taping on Postoperative Edema and Nasal Draping

We'll reach out to this number within 24 hrs