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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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.
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.
DeNova Research
Chicago, Illinois, United States
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
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
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
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
Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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
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)