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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03748459
Other study ID # 00066546
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 7, 2017
Est. completion date September 14, 2020

Study information

Verified date February 2021
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 14, 2020
Est. primary completion date September 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Closure with Permanent Suture
Skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.
Closure with Resorbable Suture
Skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty.

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States Ralph Johnson VA Medical Center Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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