RhinoplastyNCT01225250
Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty
A study testing Polydioxanone (PDS) plates and Caudal septal extension graft performed through endonasal rhinoplasty in people with Rhinoplasty, run by DeNova Research at 1 site in United States.
Trial summary
The purpose of this study is to determine efficacy, safety, and ease of cartilaginous grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as performed through an endonasal rhinoplasty approach in patients requiring a caudal septal extension (CSE) graft. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinoplasty
- What is being tested?
- Polydioxanone (PDS) plates and Caudal septal extension graft performed through endonasal rhinoplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2010to 19 Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 18 and 65 years of age.
- Subjects requesting primary or secondary rhinoplasty and requiring a CSE graft performed through an endonasal approach.
- Subjects willing to undergo PDS plating.
- Subjects with either ear conchal or septal cartilage available for grafting purposes.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Willingness and ability to comply with the PI's standard preoperative and postoperative rhinoplasty instructions.
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- Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
- postmenopausal for at least 12 months prior to study drug administration
- without a uterus and/or both ovaries
- has had a bilateral tubal ligation for at least 6 months prior to study drug administration.
- absence of an other physical condition according to the PI's discretion
- Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
- Willingness and ability to provide written informed consent prior to performance of any study related procedure.
Who cannot join
- Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
- Subjects with a significant systemic illness or illness localized to the areas of treatment.
- Subjects with previous history of nasal implants.
- Subjects with previous or current history of nasal infections.
- Subjects who have history of blood thinners (aspirin, ibuprofen, naprosyn, herbal supplements, Vitamin E) within the two weeks prior to surgery.
- Subjects who have smoked within the two weeks prior to surgery.
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- Subjects who have had alcohol or illicit drugs one week prior to surgery.
- Subjects who have eaten or drank anything after midnight the night prior to surgery.
- Subjects with current history of chronic drug or alcohol abuse.
- History of autoimmune disease.
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- Subjects who anticipate the need for surgery, other than the study procedure, or overnight hospitalization during the study.
- Subjects who, in the Investigator's opinion, have a history of poor cooperation, non compliance with medical treatment or unreliability.
- Enrollment in any active study involving the use of investigational devices or drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, 2-Arm Parallel Study Comparing the Efficacy, Ease of Use, and Safety of PDS Plated Cartilagenous Grafting Versus Non-Plated Cartilagenous Grafting as Performed Through Endonasal Rhinoplasty
The purpose of this study is to determine efficacy, safety, and ease of cartilaginous grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as performed through an endonasal rhinoplasty approach in patients requiring a caudal septal extension (CSE) graft.
- Conditions
- Rhinoplasty
- Being tested
- Polydioxanone (PDS) plates, Caudal septal extension graft performed through endonasal rhinoplasty
- Keywords
- Caudal septal extension graft, Primary rhinoplasty, Secondary rhinoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polydioxanone (PDS) platesDevice
0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.
Caudal septal extension graft performed through endonasal rhinoplastyProcedure or surgery
The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.
Caudal septal extension graft performed through endonasal rhinoplastyProcedure or surgery
The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Polydioxanone (PDS) plates | Experimental | 15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft Receives: Device: Polydioxanone (PDS) plates; Procedure: Caudal septal extension graft performed through endonasal rhinoplasty |
| Non-plated cartilagenous graft | Other | 15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft Receives: Procedure: Caudal septal extension graft performed through endonasal rhinoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Assessment of Satisfaction With the Grafts
Efficacy will be determined by a live assessment of satisfaction with the grafts at 12 months using a four-point categorical satisfaction scale ((4) unsatisfied, (3) satisfied, (2) very satisfied, (1) highly satisfied).
Scores closer to 1 indicate a more favorable outcome
Measured: 12 months post operative
Assessment of Tip Projection
Tip projection will be measured using standardized photography preoperatively and at 1 month, 3 months, 6 months, and 12 months postoperatively using Goode's Ratio.
The ratio of the line from the alar crease to the nasal tip to the nasion to the nasal tip should be 0.55. If it is more than that the nose is over projected, if it is under that ratio the nose is under projected.
Measured: 12 months Post opeartive
Non-treating Blinded Evaluator Satisfaction Assessment
A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale ((4) - unsatisfied, (3) - satisfied, (2) - very satisfied, (1) - highly satisfied) of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site.
Scores closer to 1 indicate a more favorable outcome
Measured: Assessed at baseline, 1 month, 3 months, 6 months, and 12 months; Month 12 reported
Ease of Use
Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease with a score of 0 mm being easy and a scale of 100 mm being extremely difficult.
Measured: 1 hour following surgery
Secondary outcomes (2)
Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months
Safety will be determined by rate of infection, rejection, and extrusion of the graft at 1 week, 1 month, 3 months, 6 months, and 12 months.
Measured: 12 months post surgery
Intraoperative Duration
The intraoperative duration of the grafting procedure will be measured by an assistant using a stopwatch to record the time it takes to harvest, shape, and satisfactorily secure the graft.
Measured: During surgery (up to 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study start24 Nov 2010
- Primary completion19 Jan 2015
- Study completion19 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinoplastyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Collaborators
- Mentor Worldwide, LLC
- Responsible party
- Principal investigator, Steven H. Dayan, DeNova Research
- Investigators
- Steven H Dayan, MD, Principal investigator, DeNova Research/ Chicago Center for Facial Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225250
- Sponsor's protocol ID
- PDS-END-001
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2010
- Last updated
- 4 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dayan SH, Ashourian N. Polydioxanone Absorbable Plate for Cartilaginous Grafting in Endonasal Rhinoplasty: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2016 Jan-Feb;18(1):47-53. doi: 10.1001/jamafacial.2015.1492.
PubMed 26501937
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 2-Arm Parallel Study Comparing the Efficacy, Ease of Use, and Safety of PDS Plated Cartilagenous Grafting Versus Non-Plated Cartilagenous Grafting as Performed Through Endonasal Rhinoplasty
- ClinicalTrials.gov ID
- NCT01225250
- Acronym / sponsor ID
- PDS-END-001
- Conditions
- Rhinoplasty
- Keywords
- Caudal septal extension graft, Primary rhinoplasty, Secondary rhinoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Collaborators
- Mentor Worldwide, LLC
- Study start
- 24 Nov 2010 (actual)
- Primary completion
- 19 Jan 2015 (actual)
- Study completion
- 19 Jan 2015 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Posted 4 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine efficacy, safety, and ease of cartilaginous grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as performed through an endonasal rhinoplasty approach in patients requiring a caudal septal extension (CSE) graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polydioxanone (PDS) plates | Experimental | Device: Polydioxanone (PDS) plates, Procedure: Caudal septal extension graft performed through endonasal rhinoplasty15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft |
| Non-plated cartilagenous graft | Other | Procedure: Caudal septal extension graft performed through endonasal rhinoplasty15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males and females between 18 and 65 years of age.
- Subjects requesting primary or secondary rhinoplasty and requiring a CSE graft performed through an endonasal approach.
- Subjects willing to undergo PDS plating.
- Subjects with either ear conchal or septal cartilage available for grafting purposes.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Key exclusion criteria (14 listed)
- Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
- Subjects with a significant systemic illness or illness localized to the areas of treatment.
- Subjects with previous history of nasal implants.
- Subjects with previous or current history of nasal infections.
- Subjects who have history of blood thinners (aspirin, ibuprofen, naprosyn, herbal supplements, Vitamin E) within the two weeks prior to surgery.
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 |
|---|---|---|
| Polydioxanone (PDS) plates0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction. | Device | Polydioxanone (PDS) plates |
| Caudal septal extension graft performed through endonasal rhinoplastyThe caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure. | Procedure or surgery | Polydioxanone (PDS) plates |
| Caudal septal extension graft performed through endonasal rhinoplastyThe caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure. | Procedure or surgery | Non-plated cartilagenous graft |
Primary outcome
Live Assessment of Satisfaction With the Grafts
Time frame: 12 months post operative
Efficacy will be determined by a live assessment of satisfaction with the grafts at 12 months using a four-point categorical satisfaction scale ((4) unsatisfied, (3) satisfied, (2) very satisfied, (1) highly satisfied). Scores closer to 1 indicate a more favorable outcome
Assessment of Tip Projection
Time frame: 12 months Post opeartive
Tip projection will be measured using standardized photography preoperatively and at 1 month, 3 months, 6 months, and 12 months postoperatively using Goode's Ratio. The ratio of the line from the alar crease to the nasal tip to the nasion to the nasal tip should be 0.55. If it is more than that the nose is over projected, if it is under that ratio the nose is under projected.
Non-treating Blinded Evaluator Satisfaction Assessment
Time frame: Assessed at baseline, 1 month, 3 months, 6 months, and 12 months; Month 12 reported
A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale ((4) - unsatisfied, (3) - satisfied, (2) - very satisfied, (1) - highly satisfied) of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site. Scores closer to 1 indicate a more favorable outcome
Ease of Use
Time frame: 1 hour following surgery
Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease with a score of 0 mm being easy and a scale of 100 mm being extremely difficult.
2 secondary outcomes
Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months
Time frame: 12 months post surgery
Intraoperative Duration
Time frame: During surgery (up to 3 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26501937Dayan SH, Ashourian N. Polydioxanone Absorbable Plate for Cartilaginous Grafting in Endonasal Rhinoplasty: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2016 Jan-Feb;18(1):47-53. doi: 10.1001/jamafacial.2015.1492.
- Dr. Steven H. Dayan, MD FACSLink provided by the sponsor.
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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.
Steven H Dayan, MD principal investigator
DeNova Research/ Chicago Center for Facial Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polydioxanone (PDS) plates and Caudal septal extension graft performed through endonasal rhinoplasty in people with Rhinoplasty, run by DeNova Research at 1 site 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 13 inclusion and 14 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 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Live Assessment of Satisfaction With the Grafts (time frame: 12 months post operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01225250, which also lists 1 linked publication.
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 Nov 2020.