Safety and Efficacy Study of Polydioxanone (PDS) Plates i... | NCT01225250

NCT01225250

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Mentor Worldwide, LLC	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Polydioxanone (PDS) plates	Experimental	15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft	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	Procedure: Caudal septal extension graft performed through endonasal rhinoplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polydioxanone (PDS) plates	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.	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	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.	1 hour following surgery

Secondary Outcomes

Measure	Description	Time Frame
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.	12 months post surgery
Intraoperative Duration

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Steven H Dayan, MD	DeNova Research/ Chicago Center for Facial Plastic Surgery	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
DeNova Research		Chicago	Illinois	60611	United States

PubMed Identifier	Type	Citation	Retractions
26501937	Derived	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.

Label	URL
DeNova Research	View source

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

Posted

Mean

Standard Deviation

units on a scale

12 months post operative

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

ID	Term
D016268	Internal Fixators
D019736	Prostheses and Implants
D004864	Equipment and Supplies
D009984	Orthopedic Fixation Devices