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

NCT05807087 | Completed

• 1 other identifier: NasalBoneSurgery_2021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasal Injury

Outcome Measures

Primary Outcomes (4)

• Operative time

  Operation duration will be calculated

  During procedure

• 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

• 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

• 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 Outcomes (1)

• Functional - aesthetic outcome

  immediately after procedure

Study Arms (2)

Mechanical Osteotomy

ACTIVE COMPARATOR

Procedure: Conventional osteotomy

Piezosurgery

EXPERIMENTAL

Procedure: Piezosurgery osteotomy

Interventions

Conventional osteotomy PROCEDURE

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.

Mechanical Osteotomy

Piezosurgery osteotomy PROCEDURE

full exposure of the nasal bony pyramid is needed.

Piezosurgery

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 11, 2023
• Study Start: August 1, 2021
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-03

Locations

EG (1)