Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty

NCT03213548 | Unknown

• 1 other identifier: 59622316.0.0000.5327
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Rhinoplasty is among the most accomplished aesthetic procedures in Plastic Surgery. The mastery of Alar Base modifications is essential for superior aesthetic results. The main indication is to reduce nasal width when it exceeds the intercanthal distance in Caucasian women. Other indications are the modification of the shape of the nostrils or to reduce alar flare in noses with too convex alar base. Since Wier's first description, a series of techniques has been developed with a common goal of making the basal view of the nose close to an equilateral triangle. The location and amount of tissue to be removed will be according to the preoperative or intraoperative indication due to changes in the alar base resulting from reductions in the projection of the nasal tip. One of the controversies in the literature is in the position of the incision in alar base modifications. Some authors prioritize incisions that do not violate the alar facial groove , since the groove region presents a greater number of sebaceous glands, leading to poor scarring results. Other authors have argued that incisions above the sulcus have caused more evident scars, anda that poor healing results would be more associated with aggressive resections of border and bad closing skin techniques. Due to divergence in the literature, the present study aims to compare, through a double blinded randomized clinical trial, two techniques of alar base modifications that will differentiate only by violating or not the alar facial groove.

Conditions

Rhinoplasty; Surgical Procedure, Unspecified; Surgery, Plastic; Cicatrix; Healing Scar

Keywords

alar base reduction; alar facial groove; alectomy; Flare; Nose

Outcome Measures

Primary Outcomes (1)

• Stony Brook Scar Evaluation Scale (SBSES)

  Patients will be evaluated personally by blinded examiners who will graduate the scars according to the standardized Stony Brook scoring evaluation scar which has a minimum score of 0 and a maximum score of 5 points according to 5 characteristics of the scar ( width, height, color, hatch/suture mark, overall appearance)

  90 days

Secondary Outcomes (4)

• Rhinoplasty Outcome Evaluation (ROE) Scale

  base line and 90 posoperative days

• Visual Analogue Scale - Satisfaction with aesthetic aspect of the nose

  base line and 90 posoperative days

• Intensity of nasal obstruction

  base line and 90 posoperative days

• NOSE Scale

  base line and 90 posoperative days

Study Arms (2)

Alar facial groove Incision

EXPERIMENTAL

Alar Base surgical modification with surgical inions in the alar facial groove

Procedure: Alar facial groove incision

Alar facial groove spared

ACTIVE COMPARATOR

Alar Base surgical modification with surgical incisions 1mm above the alar facial groove

Procedure: Alar facial groove spared

Interventions

Alar facial groove incision PROCEDURE

All procedures related to alterations in the alar base will be based on an algorithm proposed by 2010 Adamnson et al lar Soft-Tissue Techniques in Rhinoplasty Algorithmic Approach, Quantifiable Guidelines, and Scar Outcomes From a Single Surgeon Experience ,published at Archives Facial Plastic Surgery in which a sequential approach is used, evaluating step-by-step surgical needs. Initially, the alar base can be reduced by removing tissue from the nasal sill. At this step, modifications at the shape or the width of the nostrils can be done. After that, a rotation-advancement flap is made, and the sill defect is closed. The nasal flair is then assessed and tissue from the alar border can be removed if needed. The incisions not spare the alar facial groove.

Alar facial groove Incision

Alar facial groove spared PROCEDURE

The technique is the same of the Alar facial groove incision intervention group, but the incisions spare the groove. The incisions will be at 1 mm above the groove.

Alar facial groove spared

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from The Department of Otolaryngology of HCPA Hospital who are candidates for functional and / or aesthetic rhinoplasty over 16 years of age, with an indication of alar base modification, will be candidates for the study.
• The alar base modification is indicated when the columella-alar distance is greater than the intercanthal distance, when there is presence of asymmetries between the nostrils or its size is too width. In corrections of overprojected noses, there may be enlargement of the base of the alar, with an indication of reduction of the width of the alar at the end of the procedure.

You may not qualify if:

• Patients who present (1) Previous alar base surgery modification ; (2) keloid / hypertrophic scar history and (3) Patients with cheek - alar border obtuse angle

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (14)

• Rohrich RJ, Ahmad J. Rhinoplasty. Plast Reconstr Surg. 2011 Aug;128(2):49e-73e. doi: 10.1097/PRS.0b013e31821e7191.

  PMID: 21788798 BACKGROUND

• Kridel RW, Castellano RD. A simplified approach to alar base reduction: a review of 124 patients over 20 years. Arch Facial Plast Surg. 2005 Mar-Apr;7(2):81-93. doi: 10.1001/archfaci.7.2.81.

  PMID: 15781717 BACKGROUND

• Warner JP, Chauhan N, Adamson PA. Alar soft-tissue techniques in rhinoplasty: algorithmic approach, quantifiable guidelines, and scar outcomes from a single surgeon experience. Arch Facial Plast Surg. 2010 May-Jun;12(3):149-58. doi: 10.1001/archfacial.2010.30.

  PMID: 20479430 BACKGROUND

• Bennett GH, Lessow A, Song P, Constantinides M. The long-term effects of alar base reduction. Arch Facial Plast Surg. 2005 Mar-Apr;7(2):94-7. doi: 10.1001/archfaci.7.2.94.

  PMID: 15781718 BACKGROUND

• Weir RF. On restoring sunken noses without scarring the face. 1892. Aesthetic Plast Surg. 1988 Nov;12(4):203-6. No abstract available.

  PMID: 3068968 BACKGROUND

• Patel AD, Kridel RW. African-American rhinoplasty. Facial Plast Surg. 2010 May;26(2):131-41. doi: 10.1055/s-0030-1253499. Epub 2010 May 4.

  PMID: 20446207 BACKGROUND

• Foda HM. Nasal base narrowing: the combined alar base excision technique. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):30-4. doi: 10.1001/archfaci.9.1.30.

  PMID: 17224485 BACKGROUND

• Boyette JR, Stucker FJ. African American rhinoplasty. Facial Plast Surg Clin North Am. 2014 Aug;22(3):379-93. doi: 10.1016/j.fsc.2014.04.004.

  PMID: 25049123 BACKGROUND

• Stucker FJ, Lian T, Sanders K. African American rhinoplasty. Facial Plast Surg Clin North Am. 2005 Feb;13(1):65-72. doi: 10.1016/j.fsc.2004.04.010.

  PMID: 15519928 BACKGROUND

• Porter JP. The average African American male face: an anthropometric analysis. Arch Facial Plast Surg. 2004 Mar-Apr;6(2):78-81. doi: 10.1001/archfaci.6.2.78.

  PMID: 15023793 BACKGROUND

• Tardy ME Jr, Patt BS, Walter MA. Alar reduction and sculpture: anatomic concepts. Facial Plast Surg. 1993 Oct;9(4):295-305. doi: 10.1055/s-2008-1064623. No abstract available.

  PMID: 8181769 BACKGROUND

• Hagan KF. Clinical photography for the plastic surgery practice--the basics. Plast Surg Nurs. 2008 Oct-Dec;28(4):188-92; 193-4. doi: 10.1097/01.PSN.0000342822.44387.c5.

  PMID: 19092585 BACKGROUND

• Swamy RS, Sykes JM, Most SP. Principles of photography in rhinoplasty for the digital photographer. Clin Plast Surg. 2010 Apr;37(2):213-21. doi: 10.1016/j.cps.2009.12.003.

  PMID: 20206739 BACKGROUND

• Lima LF, Arroyo HH, Jurado JR. Update in alar base reduction in rhinoplasty. Curr Opin Otolaryngol Head Neck Surg. 2016 Aug;24(4):316-21. doi: 10.1097/MOO.0000000000000277.

  PMID: 27261942 RESULT

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Lavinsky, PHD

  Porto Alegre Clinicas Hospital ( HCPA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Pedro Garcia, MD

CONTACT

+5551996154290; jptg@terra.com.br

João Pedro Garcia, MD

CONTACT

+55996154290; jptg@terra.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blind clinical trial

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 11, 2017
• Study Start: September 15, 2017
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2020
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

BR (1)