Rhinoplasty Scar Comparison

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748459
• Other study ID #: 00066546
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Nose Deformity
• Surgical Incision
• Surgical Wound

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