Comparison of Conventional Techniques & Piezosurgery in the Management of the Nasal Bony Pyramid

Nasal Injury Clinical Trial

Official title:

Prospective Randomized Study Between Conventional Techniques & Piezosurgery in the Management of Nasal Bony Pyramid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05807087
• Other study ID #: NasalBoneSurgery_2021
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: September 16, 2022

Study information

• Verified date: March 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is well-known and universally acknowledged that rhinoplasty is the most demanding procedure in facial aesthetic surgery. Postoperatively nasal osteotomies result in variable degrees of edema and ecchymosis and surgeons have tried various techniques, instruments, and postoperative methods to diminish these uncomfortable morbidities. Piezosurgery is used nowadays to decrease the incidence of injured soft tissues and vital structures passing near the osteotomy line. Its use in rhinoplasty was advocated to prevent unwanted back fractures as well as to decrease bleeding while keeping the nasal mucosa intact thus minimizing postoperative sequelae.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients requesting aesthetic rhinoplasty, post-traumatic rhinoplasty, and post-cleft nose rhinoplasty.

Exclusion Criteria:

• Patients with severe systemic disease (American Society of Anesthesiologists physical status classification system III & IV).

• Psychological disorders.

• Female patients younger than 16 years of age and male patients younger than 18 years of age.

• Patients with autoimmune and skin diseases.

Related Conditions & MeSH terms

• Nasal Injury

Intervention

Procedure:
• Conventional osteotomy
The nasal skeleton was accessed using a closed approach or an open approach is done via a transcolumellar and infracartilaginous incision. Osteotomy was made using osteotomes.
• Piezosurgery osteotomy
full exposure of the nasal bony pyramid is needed.

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria	Azarita

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Operation duration will be calculated	During procedure
Primary	Visual analogue score	The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')	immediately after procedure
Primary	Change in periorbital edema	Grade 1 - No coverage of iris with eyelids, Grade 2 - Slight coverage of iris with swollen eyelids, Grade 3 - Full coverage of iris with swollen eyelids, Grade 4 - Full closure of eyes.	Baseline and 1 week
Primary	Change in eccyhmosis	Grade 1 - Eccyhmosis upto the medial one-third part of lower and /or upper eyelid, Grade 2 - Ecchymosis upto the medial two-third part of the lower and/or upper eyelid. Grade 3 - Ecchymosis up to the full length and /or upper eyelid.	Baseline and 1 week
Secondary	Functional - aesthetic outcome	The SCHNOS is a 10-item self-rated questionnaire that uses a Likert-like 0-5 scale ('no problem' to 'extreme problem'). The SCHNOS does not produce a combined total score, but two scores - one for each domain, an obstruction score (SCHNOS-O) and a cosmesis score (SCHNOS-C) The SCHNOS-O is calculated as a sum of scores of items 1-4 divided by 20 and multiplied by 100. The SCHNOS-C score is calculated as a sum of scores of items 5-10 divided by 30 and multiplied by 100.	immediately after procedure