Rhinoplasty Scar Comparison

NCT ID: NCT03748459

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-07

Study Completion Date

2020-09-14

Brief Summary

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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

Detailed Description

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Conditions

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Surgical Incision Nose Deformity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Permanent suture

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

Closure with Permanent Suture

Intervention Type OTHER

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

Resorbable suture

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

Closure with Resorbable Suture

Intervention Type OTHER

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

Interventions

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Closure with Permanent Suture

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

Intervention Type OTHER

Closure with Resorbable Suture

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Ralph Johnson VA Medical Center

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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00066546

Identifier Type: -

Identifier Source: org_study_id

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