Surgical Incision Clinical Trial
Official title:
Patient and Observer Graded Rhinoplasty Scar Outcomes: A Randomized-Controlled Trial of Fast Absorbing Versus Permanent Columellar Suture Closure
Verified date | February 2021 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Ralph Johnson VA Medical Center | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
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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