Rhinoplasty
Conditions
Keywords
Caudal septal extension graft, Primary rhinoplasty, Secondary rhinoplasty
Brief 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.
Interventions
DEVICEPolydioxanone (PDS) plates
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.
PROCEDURECaudal septal extension graft performed through endonasal rhinoplasty
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.
Sponsors
Mentor Worldwide, LLC
DeNova Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live Assessment of Satisfaction With the Grafts | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | 12 months post surgery | 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. |
| Intraoperative Duration | During surgery (up to 3 hours) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polydioxanone (PDS) Plates 15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft
Polydioxanone (PDS) plates: 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 rhinoplasty: 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. | 15 |
| Non-plated Cartilagenous Graft 15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft
Caudal septal extension graft performed through endonasal rhinoplasty: 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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Non-plated Cartilagenous Graft | Polydioxanone (PDS) Plates | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 48 years | 49 years | 48.5 years |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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.
Time frame: 12 months Post opeartive
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Polydioxanone (PDS) Plates | Assessment of Tip Projection | Month 1 | 0.55 ratio of tip projection to nasal length | Standard Deviation 0.6 |
| Polydioxanone (PDS) Plates | Assessment of Tip Projection | Month 3 | 0.54 ratio of tip projection to nasal length | Standard Deviation 0.06 |
| Polydioxanone (PDS) Plates | Assessment of Tip Projection | Month 6 | 0.54 ratio of tip projection to nasal length | Standard Deviation 0.05 |
| Polydioxanone (PDS) Plates | Assessment of Tip Projection | Month 12 | 0.55 ratio of tip projection to nasal length | Standard Deviation 0.06 |
| Non-plated Cartilagenous Graft | Assessment of Tip Projection | Month 12 | 0.55 ratio of tip projection to nasal length | Standard Deviation 0.05 |
| Non-plated Cartilagenous Graft | Assessment of Tip Projection | Month 1 | 0.58 ratio of tip projection to nasal length | Standard Deviation 0.05 |
| Non-plated Cartilagenous Graft | Assessment of Tip Projection | Month 6 | 0.57 ratio of tip projection to nasal length | Standard Deviation 0.03 |
| Non-plated Cartilagenous Graft | Assessment of Tip Projection | Month 3 | 0.58 ratio of tip projection to nasal length | Standard Deviation 0.04 |
Primary
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.
Time frame: 1 hour following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Polydioxanone (PDS) Plates | Ease of Use | 17 score on a scale | Standard Deviation 9.95 |
| Non-plated Cartilagenous Graft | Ease of Use | 46.4 score on a scale | Standard Deviation 13.43 |
Primary
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
Time frame: 12 months post operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Polydioxanone (PDS) Plates | Live Assessment of Satisfaction With the Grafts | 2 units on a scale | Standard Deviation 0.667 |
| Non-plated Cartilagenous Graft | Live Assessment of Satisfaction With the Grafts | 4 units on a scale | Standard Deviation 0.05 |
Primary
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
Time frame: Assessed at baseline, 1 month, 3 months, 6 months, and 12 months; Month 12 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Polydioxanone (PDS) Plates | Non-treating Blinded Evaluator Satisfaction Assessment | 2 score on a scale | Standard Error 1 |
| Non-plated Cartilagenous Graft | Non-treating Blinded Evaluator Satisfaction Assessment | 2 score on a scale | Standard Error 1 |
Secondary
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.
Time frame: During surgery (up to 3 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Polydioxanone (PDS) Plates | Intraoperative Duration | 604.7 seconds | Standard Deviation 219.12 |
| Non-plated Cartilagenous Graft | Intraoperative Duration | 571.5 seconds | Standard Deviation 182.16 |
Secondary
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.
Time frame: 12 months post surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Week 1 - Rejection | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 1 - Extrusion | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 6 - Extrusion | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 3 - Infection | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Week 1 - Extrusion | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 3 - Rejection | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Week 1 - Infection | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 3 - Extrusion | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 1 - Infection | 1 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 6 - Infection | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 12 - Infection | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 12 - Rejection | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 1 - Rejection | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 12 - Extrusion | 0 Participants |
| Polydioxanone (PDS) Plates | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 6 - Rejection | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 12 - Extrusion | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 6 - Rejection | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 6 - Extrusion | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 12 - Infection | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Week 1 - Infection | 1 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Week 1 - Rejection | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Week 1 - Extrusion | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 1 - Infection | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 1 - Rejection | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 1 - Extrusion | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 3 - Infection | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 3 - Rejection | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 3 - Extrusion | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 6 - Infection | 0 Participants |
| Non-plated Cartilagenous Graft | Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months | Month 12 - Rejection | 0 Participants |