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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

Tracking Information
First Submitted Date November 19, 2018
First Posted Date November 20, 2018
Last Update Posted Date November 20, 2018
Actual Study Start Date December 7, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2018)
  • 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)
  • 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rhinoplasty Scar Comparison
Official Title Patient and Observer Graded Rhinoplasty Scar Outcomes: A Randomized-Controlled Trial of Fast Absorbing Versus Permanent Columellar Suture Closure
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients seeking rhinoplasty surgery with one of the investigators.
Condition
  • Surgical Incision
  • Nose Deformity
Intervention
  • Other: Closure with Permanent Suture
    Skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.
  • Other: Closure with Resorbable Suture
    Skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty.
Study Groups/Cohorts
  • Permanent suture
    Subjects will have skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.
    Intervention: Other: Closure with Permanent Suture
  • Resorbable suture
    Subjects will have skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty
    Intervention: Other: Closure with Resorbable Suture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 19, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sam Oyer, MD 843-876-5039 oyer@musc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03748459
Other Study ID Numbers 00066546
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Samuel Oyer, Medical University of South Carolina
Study Sponsor Medical University of South Carolina
Collaborators Not Provided
Investigators Not Provided
PRS Account Medical University of South Carolina
Verification Date November 2018