Clinical trial NCT06094348: The Evaluation of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty
Official title: The Evaluation of the Effect of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty by the Ultrasonic Measurement of Nasal Skin Thickness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasal Deformity, Acquired
Septum; Deviation, Congenital
Keywords: rhinoplasty
edema
piezosurgery
osteotomy
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-65 year, males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure.

Brief summary: The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question\[s\] it aims to answer are:

* In which osteotomy technique the edema is lesser?
* Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster?

Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively.

Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements)

Detailed description: The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question\[s\] it aims to answer are:

* In which osteotomy technique the edema is lesser?
* Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster?

18-65 years old males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure will be included in the study. Patients who have a history of previous rhinoplasty/septorhinoplasty procedure, abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time), use of anticoagulant drugs, chronic / inflammatory skin disease and/or chronic skin allergies, systemic diseases (hypertension, diabetes mellitus, bronchial asthma), nasal beautification procedures such as dermal fillings, using oral and/or topical (nasal skin) corticosteroids in three months preoperatively will be excluded.

Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively.

Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements).

Eligibility criteria: Inclusion Criteria:

* nasal respiratory dysfunction with the deviation of nasal septum and/or the nasal pyramid

Exclusion Criteria:

* previous rhinoplasty/septorhinoplasty procedure
* patients with abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time)
* use of anticoagulant drugs
* chronic / inflammatory skin disease and/or chronic skin allergies
* presence of systemic diseases (hypertension, diabetes mellitus, bronchial asthma)
* nasal beautification procedures such as dermal fillings
* use of oral and/or topical (nasal skin) corticosteroids in three months preoperatively

Primary outcomes:
measure: the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10th month
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
Study officials:
affiliation: Haseki Training and Research Hospiral
name: Isil Taylan Cebi, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gode S, Ozturk A, Kismali E, Berber V, Turhal G. The Effect of Platelet-Rich Fibrin on Nasal Skin Thickness in Rhinoplasty. Facial Plast Surg. 2019 Aug;35(4):400-403. doi: 10.1055/s-0039-1693436. Epub 2019 Jul 15.
citation: Erdur ZB, Oktem F, Inci E, Yener HM, Ustundag A. Effect of Nasal Soft-Tissue Envelope Thickness on Postoperative Healing Process Following Rhinoplasty. J Craniofac Surg. 2021 Sep 1;32(6):2193-2197. doi: 10.1097/SCS.0000000000007697.
citation: Stenner M, Koopmann M, Rudack C. Measuring the nose in septorhinoplasty patients: ultrasonographic standard values and clinical correlations. Eur Arch Otorhinolaryngol. 2017 Feb;274(2):855-860. doi: 10.1007/s00405-016-4296-7. Epub 2016 Sep 15.
citation: Tsikopoulos A, Tsikopoulos K, Doxani C, Vagdatli E, Meroni G, Skoulakis C, Stefanidis I, Zintzaras E. Piezoelectric or Conventional Osteotomy in Rhinoplasty? A Systematic Review and Meta-Analysis of Clinical Outcomes. ORL J Otorhinolaryngol Relat Spec. 2020;82(4):216-234. doi: 10.1159/000506707. Epub 2020 Apr 22.
citation: Kurt Yazar S, Serin M, Rakici IT, Sirvan SS, Irmak F, Yazar M. Comparison of piezosurgery, percutaneous osteotomy, and endonasal continuous osteotomy techniques with a caprine skull model. J Plast Reconstr Aesthet Surg. 2019 Jan;72(1):107-113. doi: 10.1016/j.bjps.2018.08.025. Epub 2018 Sep 4.