Trial Outcomes & Findings for Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty (NCT NCT01225250)

Last Updated: 2020-11-04

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

12 months post operative

Results posted on

2020-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	15	15
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polydioxanone (PDS) Plates n=15 Participants 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.	Non-plated Cartilagenous Graft n=15 Participants 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.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	49 years n=5 Participants	48 years n=7 Participants	48.5 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post operative

Outcome measures

Outcome measures
Measure	Polydioxanone (PDS) Plates n=15 Participants 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.	Non-plated Cartilagenous Graft n=15 Participants 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.
Live Assessment of Satisfaction With the Grafts	2 units on a scale Standard Deviation 0.667	4 units on a scale Standard Deviation 0.05

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polydioxanone (PDS) Plates n=15 Participants 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.	Non-plated Cartilagenous Graft n=15 Participants 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.
Assessment of Tip Projection Month 1	0.55 ratio of tip projection to nasal length Standard Deviation 0.6	0.58 ratio of tip projection to nasal length Standard Deviation 0.05
Assessment of Tip Projection Month 3	0.54 ratio of tip projection to nasal length Standard Deviation 0.06	0.58 ratio of tip projection to nasal length Standard Deviation 0.04
Assessment of Tip Projection Month 6	0.54 ratio of tip projection to nasal length Standard Deviation 0.05	0.57 ratio of tip projection to nasal length Standard Deviation 0.03
Assessment of Tip Projection Month 12	0.55 ratio of tip projection to nasal length Standard Deviation 0.06	0.55 ratio of tip projection to nasal length Standard Deviation 0.05

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Polydioxanone (PDS) Plates n=15 Participants 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.	Non-plated Cartilagenous Graft n=15 Participants 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.
Non-treating Blinded Evaluator Satisfaction Assessment	2 score on a scale Standard Error 1	2 score on a scale Standard Error 1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polydioxanone (PDS) Plates n=15 Participants 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.	Non-plated Cartilagenous Graft n=15 Participants 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.
Ease of Use	17 score on a scale Standard Deviation 9.95	46.4 score on a scale Standard Deviation 13.43

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polydioxanone (PDS) Plates n=15 Participants 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.	Non-plated Cartilagenous Graft n=15 Participants 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.
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	1 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polydioxanone (PDS) Plates n=15 Participants 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.	Non-plated Cartilagenous Graft n=15 Participants 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.
Intraoperative Duration	604.7 seconds Standard Deviation 219.12	571.5 seconds Standard Deviation 182.16

Adverse Events

Polydioxanone (PDS) Plates

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-plated Cartilagenous Graft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven Dayan, MD

DeNova Research

Phone: 3123352070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place