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Original Investigation
Jan/Feb 2016

Polydioxanone Absorbable Plate for Cartilaginous Grafting in Endonasal RhinoplastyA Randomized Clinical Trial

Author Affiliations
  • 1DeNova Research, Chicago, Illinois
  • 2Chicago Center for Facial Plastic Surgery, Chicago, Illinois
  • 3Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology, University of Illinois Medical Center, Chicago
JAMA Facial Plast Surg. 2016;18(1):47-53. doi:10.1001/jamafacial.2015.1492
Abstract

Importance  The caudal septal extension (CSE) graft maneuver commonly is used to adjust the nasal tip projection. It can, however, be difficult to stabilize and straighten the CSE graft, especially when the procedure is performed through an endonasal approach. Because the stabilization and correct positioning of the CSE graft are vital for achievement of the desired outcome, new approaches must be found that facilitate the technical ease of this procedure.

Objective  To assess the safety and efficacy of the polydioxanone (PDS) absorbable plate in CSE graft procedures performed via an endonasal approach.

Design, Setting, and Participants  In an open-label, 2-arm parallel trial, 30 patients who requested a surgical nasal correction and required a CSE graft performed via an endonasal approach were randomized into 2 groups of 15 patients each. All patients underwent endonasal rhinoplasty at a single center from February 17, 2011, to December 26, 2013. Depending on their treatment group, patients received a CSE graft with or without a PDS plate. Data were collected and evaluated from November 24, 2010, to January 19, 2015, when final follow-up occurred. Data were analyzed based on an evaluable population.

Interventions  Endonasal rhinoplasty with or without the use of a PDS plate.

Main Outcomes and Measures  Technical difficulty assessed using a visual analog scale (range, 0-100; higher scores indicate increased difficulty of use), surgeon and blinded evaluator satisfaction with the graft assessed using a 4-point categorical scale (1 indicates highly satisfied; 4, unsatisfied), change in nasal tip projection, and complications at 30, 60, 180, and 365 days after surgery.

Results  Twenty-seven patients (13 in the PDS group and 14 in the non-PDS group) completed their 6-month postoperative visit, and 19 patients (10 in the PDS group and 9 in the non-PDS group) completed the entire study (12 months). The mean (SD; range) surgeon-assessed visual analog scale score for ease of use was 46 (13; 25-64) mm for the 15 patients in the non-PDS treatment group and 17 (10; 7-48) mm for the 15 patients in the PDS group (P < .001). The surgeon’s satisfaction with the graft did not differ significantly between the PDS and the non-PDS groups (P = .34), and the nontreating blinded evaluator’s assessment of standardized photographs taken at the time of the graft placement and at postoperative days 30, 60, 180, and 365 did not establish any significant differences between the 2 groups (P > .99). Postoperative change in the nasal tip projection at 365 postoperative days compared with 30 postoperative days was significantly lower in the PDS group compared with the non-PDS group (−0.31% vs −6.5%; P = .04), thus increasing the long-term stability of the graft in the PDS group. A single incident of infection was observed in each group along with no episodes of rejection or extrusion.

Conclusions and Relevance  In this study, use of a PDS plate in CSE graft procedures was associated with less technical difficulty than CSE graft procedures without use of a PDS plate and with reduced long-term variations in the nasal tip projection after the graft placement.

Level of Evidence  1.

Trial Registration  clinicaltrials.gov Identifier: NCT01225250

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