Surgical IncisionNCT03748459
Rhinoplasty Scar Comparison
An observational study of Surgical Incision and Nose Deformity, run by Medical University of South Carolina at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Surgical Incision, Nose Deformity
- What is being tested?
- Closure with Permanent Suture and Closure with Resorbable Suture
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Dec 2017to 14 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients seeking rhinoplasty surgery with one of the investigators.
Who may be able to join
- •Adult (age ≥ 18 years) patients undergoing primary open rhinoplasty surgery for any reason with any of the study surgeons.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Ralph Johnson VA Medical Center
Charleston, South Carolina, 29425
About this study
Official title: Patient and Observer Graded Rhinoplasty Scar Outcomes: a Randomized-Controlled Trial of Fast Absorbing Versus Permanent Columellar Suture Closure
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
- Conditions
- Surgical Incision, Nose Deformity
- Being tested
- Closure with Permanent Suture, Closure with Resorbable Suture
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure with Permanent SutureOther
Skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.
Closure with Resorbable SutureOther
Skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty.
| Study group | Role | What they receive |
|---|---|---|
| Permanent suture | Subjects will have skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty. Receives: Other: Closure with Permanent Suture | |
| Resorbable suture | Subjects will have skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty Receives: Other: Closure with Resorbable Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months after surgery
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)
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start7 Dec 2017
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748459
- Sponsor's protocol ID
- 00066546
- Status last verified
- Aug 2024
- First submitted
- 19 Nov 2018
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Observer Graded Rhinoplasty Scar Outcomes: a Randomized-Controlled Trial of Fast Absorbing Versus Permanent Columellar Suture Closure
- ClinicalTrials.gov ID
- NCT03748459
- Acronym / sponsor ID
- 00066546
- Conditions
- Surgical Incision, Nose Deformity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Permanent suture | – | Other: Closure with Permanent SutureSubjects will have skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty. |
| Resorbable suture | – | Other: Closure with Resorbable SutureSubjects will have skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients seeking rhinoplasty surgery with one of the investigators.
Key inclusion criteria (1 listed)
- •Adult (age ≥ 18 years) patients undergoing primary open rhinoplasty surgery for any reason with any of the study surgeons.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closure with Permanent SutureSkin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty. | Other | Permanent suture |
| Closure with Resorbable SutureSkin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty. | Other | Resorbable suture |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Incision and Nose Deformity, run by Medical University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Scar Assessment (time frame: 12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.