Clinical trial NCT02626585: The Effect of Postrhinoplasty Taping on Postoperative Edema and Nasal Draping
Official title: The Effect of Postrhinoplasty Taping on Postoperative Edema and Nasal Draping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Deformity
Edema
Rhinoplasty
Keywords: rhinoplasty
postrhinoplasty taping
edema
draping
postoperative edema
nasal skin thickness
supratip fullness
postoperative swelling
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 57
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in nasal skin thickness (for rhinion, radix, supratip and tip)
timeFrame: preoperative, postoperative 1st, 3rd and 5th week, postoperative 6th month
Secondary outcomes:
measure: Duration of Operation
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
affiliation: Bezmialem Vakif University
name: Berke Ozucer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.
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.