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Rhinoplasty Scar Comparison

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ClinicalTrials.gov Identifier: NCT03748459
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel Oyer, Medical University of South Carolina

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

Condition or disease Intervention/treatment
Surgical Incision Nose Deformity Other: Closure with Permanent Suture Other: Closure with Resorbable Suture

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Patient and Observer Graded Rhinoplasty Scar Outcomes: A Randomized-Controlled Trial of Fast Absorbing Versus Permanent Columellar Suture Closure
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Group/Cohort Intervention/treatment
Permanent suture
Subjects will have skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.
Other: Closure with Permanent Suture
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
Other: Closure with Resorbable Suture
Skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty.




Primary Outcome Measures :
  1. Patient Scar Assessment [ Time Frame: 12 months after surgery ]
    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)

  2. Clinician Scar Assessment [ Time Frame: 12 months after surgery ]
    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)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients seeking rhinoplasty surgery with one of the investigators.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748459


Contacts
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Contact: Sam Oyer, MD 843-876-5039 oyer@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Sam Oyer, MD         
Ralph Johnson VA Medical Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Sam Oyer, MD         
Sponsors and Collaborators
Medical University of South Carolina

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Responsible Party: Samuel Oyer, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03748459     History of Changes
Other Study ID Numbers: 00066546
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries