Rhinoplasty Scar Comparison

Study Overview
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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

Official Title
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Patient and Observer Graded Rhinoplasty Scar Outcomes: A Randomized-Controlled Trial of Fast Absorbing Versus Permanent Columellar Suture Closure

Conditions
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Surgical Incision, Nose Deformity

Intervention / Treatment
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* Other: Closure with Permanent Suture
* Other: Closure with Resorbable Suture


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Permanent suture<br>Subjects will have skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty. | Other: Closure with Permanent Suture<br>* Skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.<br>|
| Resorbable suture<br>Subjects will have skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty | Other: Closure with Resorbable Suture<br>* Skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |