Rhinoplasty Scar Comparison

NCT03748459 | Completed

• 1 other identifier: 00066546
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Traditional suture closure of the columellar scar in rhinoplasty is achieved with permanent skin sutures. These sutures create less inflammation and are thought to lead to improved final scar outcomes. However, permanent sutures require removal which creates pain and inconvenience for the patient. Some surgeons use fast absorbing sutures that do not require removal. The difference in final scar outcome based on suture material used has not been well studied. This study will examine the final scar outcomes of rhinoplasty incisions sutured with traditional permanent suture compared to fast absorbing suture. If scar outcomes are similar between these groups as judged by the patients and blinded observers, rhinoplasty surgeons may be able to preferentially utilize absorbable sutures for incision closure and avoid the pain and inconvenience for the patient during suture removal

Conditions

Surgical Incision; Nose Deformity

Outcome Measures

Primary Outcomes (2)

• Patient Scar Assessment

  Patient scar assessment will be done with a patient completed questionnaire. The questionnaire is a validated scar assessment instrument for self rating of surgical scars by patients for a minimum rating of 28 (best scar) to 112 (worst scar)

  12 months after surgery

• Clinician Scar Assessment

  Clinician scar assessment will be done using photographs of the scar 12 months after surgery. Clinicians will use a validated clinician scar grading tool for evaluation of surgical scars with a range of 0 (worst scar) to 5 (best scar)

  12 months after surgery

Study Arms (2)

Permanent suture

Subjects will have skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.

Other: Closure with Permanent Suture

Resorbable suture

Subjects will have skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty

Other: Closure with Resorbable Suture

Interventions

Closure with Permanent Suture OTHER

Skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.

Permanent suture

Closure with Resorbable Suture OTHER

Skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty.

Resorbable suture

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients seeking rhinoplasty surgery with one of the investigators.

You may qualify if:

• Adult (age ≥ 18 years) patients undergoing primary open rhinoplasty surgery for any reason with any of the study surgeons.

You may not qualify if:

• Patients undergoing rhinoplasty for cleft nasal deformity or nasal reconstruction related to cancer resection
• Patients with previous surgery that involved a columellar incision. Patients with history of previous nasal surgery that did not involve an incision on the columella may be included
• Patients with known history of cutaneous disorder that affects scaring such as personal history of keloid formation, collagen vascular disease, or previous radiation to the surgical site
• Inability or unwillingness of subject to give informed consent

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Ralph Johnson VA Medical Center

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 20, 2018
• Study Start: December 7, 2017
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: September 4, 2024

Record last verified: 2024-08

Locations

US (2)