Nasal DeformityPRTNCT02626585
The Effect of Postrhinoplasty Taping on Postoperative Edema and Nasal Draping
A study testing Postrhinoplasty taping in people with Nasal Deformity and Edema, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Nasal Deformity, Edema, Rhinoplasty
- What is being tested?
- Postrhinoplasty taping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- primary open approach rhinoplasty under general anesthesia
- bilateral lateral osteotomies
Who cannot join
- revision cases
- abnormal haemostatic parameters
- drug history of decongestant or cortisone
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Nasal Deformity, Edema, Rhinoplasty
- Being tested
- Postrhinoplasty taping
- Keywords
- rhinoplasty, postrhinoplasty taping, edema, draping, postoperative edema, nasal skin thickness, supratip fullness, postoperative swelling
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postrhinoplasty tapingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: Postrhinoplasty taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nasal skin thickness (for rhinion, radix, supratip and tip)
measured with Ultrasonography
Measured: preoperative, postoperative 1st, 3rd and 5th week, postoperative 6th month
Secondary outcomes (1)
Duration of Operation
(minutes)(incision to closure duration)
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nasal DeformityStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berke Özücer, Bezmialem Vakif University
- Investigators
- Berke Ozucer, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626585
- Sponsor's protocol ID
- BezmialemVU-BO-PRT
- Acronym
- PRT
- Status last verified
- Dec 2015
- First submitted
- 7 Dec 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 16805376Guyuron 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.
PubMed 10724276Rees 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.
PubMed 5544202Hoefflin 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.
PubMed 2748764Vega-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.
PubMed 7604101Belek 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.
PubMed 24396072Ozucer 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.
PubMed 26914594
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postrhinoplasty Taping on Postoperative Edema and Nasal Draping
- ClinicalTrials.gov ID
- NCT02626585
- Acronym / sponsor ID
- PRT / BezmialemVU-BO-PRT
- Conditions
- Nasal Deformity, Edema, Rhinoplasty
- Keywords
- rhinoplasty, postrhinoplasty taping, edema, draping, postoperative edema, nasal skin thickness, supratip fullness, postoperative swelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Postrhinoplasty taping2-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 | Experimental | Procedure: Postrhinoplasty taping4-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). |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- primary open approach rhinoplasty under general anesthesia
- bilateral lateral osteotomies
Key exclusion criteria (3 listed)
- revision cases
- abnormal haemostatic parameters
- drug history of decongestant or cortisone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postrhinoplasty tapingPostrhinoplasty 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 | Procedure or surgery | 2-weeks of PRT, 4-weeks of PRT |
Primary outcome
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
1 secondary outcome
Duration of Operation
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Background: PubMed 16805376Hafezi 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.
- Background: PubMed 10724276Guyuron 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.
- Background: PubMed 5544202Rees 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.
- Background: PubMed 2748764Hoefflin 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.
- Background: PubMed 7604101Vega-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.
- Background: PubMed 24396072Belek 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.
- Derived from this study: PubMed 26914594Ozucer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berke Ozucer, MD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postrhinoplasty taping in people with Nasal Deformity and Edema, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nasal skin thickness (for rhinion, radix, supratip and tip) (time frame: preoperative, postoperative 1st, 3rd and 5th week, postoperative 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02626585, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.