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OpenTrials
Completed

NCT Number: NCT03748459

Rhinoplasty Scar Comparison

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina, Charleston, South Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closure with Permanent Suture

Other

Skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.

Closure with Resorbable Suture

Other

Skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty.

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Patient and Observer Graded Rhinoplasty Scar Outcomes: a Randomized-Controlled Trial of Fast Absorbing Versus Permanent Columellar Suture Closure

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2018
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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