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

December 8, 2015 updated by: Berke Özücer, Bezmialem Vakif University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bezmialem Vakıf University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control group (n=20): Following removal of nasal cast on postoperative first week, no additional taping was applied to this group.
Experimental: 2-weeks of PRT
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
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
Experimental: 4-weeks of PRT
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in nasal skin thickness (for rhinion, radix, supratip and tip)
Time Frame: preoperative, postoperative 1st, 3rd and 5th week, postoperative 6th month
measured with Ultrasonography
preoperative, postoperative 1st, 3rd and 5th week, postoperative 6th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Operation
Time Frame: Intraoperative
(minutes)(incision to closure duration)
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Berke Ozucer, MD, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BezmialemVU-BO-PRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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