Polydioxanone Absorbable Plate for Cartilaginous Grafting in Endonasal Rhinoplasty

Abstract

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 pla...

Polydioxanone plates are safe and effective for L‐strut support in functional septorhinoplasty

“…To our knowledge, there are no studies reporting increased rates of infection in pediatric patients. This rate of infection is much less than that of nonabsorbable alloplastic implants used in adults and is similar to infection rates seen using autologous cartilage grafts in adults . This suggests that PDS is safe for use in septorhinoplasty and does not increase the rate of infection beyond that seen with autologous cartilage.…”

“…This rate of infection is much less than that of nonabsorbable alloplastic implants used in adults and is similar to infection rates seen using autologous cartilage grafts in adults. [1][2][3][5][6][7][8][9][10][11][12] This suggests that PDS is safe for use in septorhinoplasty and does not increase the rate of infection beyond that seen with autologous cartilage. However, closer inspection into the pediatric population is warranted.…”

“…The PDS plates are available in various sizes and thicknesses, can be trimmed to their desired shape, provide rigid support, and can be fixed to the existing cartilage with sutures . Animal and human studies have demonstrated the plates to be well tolerated with low rates of infection . These plates were previously used for bone defects and orbital reconstruction with good effect .…”

“…5 Animal and human studies have demonstrated the plates to be well tolerated with low rates of infection. 5,[8][9][10][11][12] These plates were previously used for bone defects and orbital reconstruction with good effect. 13,14 More recently, they have been successfully used for septal defects during septoplasty and septorhinoplasty for support of cartilage grafts.…”

“…13,14 More recently, they have been successfully used for septal defects during septoplasty and septorhinoplasty for support of cartilage grafts. 4,[8][9][10]15 In this study, we sought to evaluate the safety and efficacy of PDS plate use for L-strut stabilization in primary and revision septorhinoplasty for patients with symptomatic nasal obstruction and nasal valve compromise, and to evaluate the long-term stability of results beyond the time of PDS absorption through use of the Nasal Obstruction Symptom Evaluation (NOSE) scale.…”