Dayan Steven H, Ashourian Nazanin
DeNova Research, Chicago, Illinois2Chicago Center for Facial Plastic Surgery, Chicago, Illinois3Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology, University of Illinois Medical Center, Chicago.
DeNova Research, Chicago, Illinois2Chicago Center for Facial Plastic Surgery, Chicago, Illinois.
JAMA Facial Plast Surg. 2016 Jan-Feb;18(1):47-53. doi: 10.1001/jamafacial.2015.1492.
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.
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.
Endonasal rhinoplasty with or without the use of a PDS plate.
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.
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.
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.
clinicaltrials.gov Identifier: NCT01225250.
尾侧鼻中隔延伸（CSE）移植操作常用于调整鼻尖突出度。然而，稳定和拉直CSE移植片可能会很困难，尤其是通过鼻内入路进行该手术时。由于CSE移植片的稳定和正确定位对于实现预期效果至关重要，因此必须找到有助于简化该手术技术操作的新方法。
评估聚二氧六环酮（PDS）可吸收板在经鼻内入路的CSE移植手术中的安全性和有效性。
设计、地点和参与者：在一项开放标签、双臂平行试验中，30例要求进行鼻部手术矫正且需要通过鼻内入路进行CSE移植的患者被随机分为两组，每组15例。所有患者于2011年2月17日至2013年12月26日在单一中心接受鼻内隆鼻术。根据治疗组的不同，患者接受带或不带PDS板的CSE移植。数据收集时间为2010年11月24日至2015年1月19日，即最后一次随访时。基于可评估人群进行数据分析。
使用或不使用PDS板的鼻内隆鼻术。
使用视觉模拟量表（范围为0 - 100；分数越高表示使用难度越大）评估技术难度，使用4分分类量表（1表示非常满意；4表示不满意）评估外科医生和非参与治疗的评估者对移植片的满意度，测量鼻尖突出度的变化，以及术后30、60、180和365天的并发症情况。
27例患者（PDS组13例，非PDS组14例）完成了术后6个月的随访，19例患者（PDS组10例，非PDS组9例）完成了整个研究（12个月）。非PDS治疗组的15例患者中，外科医生评估的使用视觉模拟量表平均（标准差；范围）得分为46（13；25 - 64）mm，PDS组的15例患者为17（10；7 - 48）mm（P <.001）。PDS组和非PDS组外科医生对移植片的满意度无显著差异（P =.34），非参与治疗的评估者对移植片放置时及术后30、60、180和365天拍摄的标准化照片的评估在两组之间未发现任何显著差异（P >.99）。与非PDS组相比，PDS组术后365天与术后30天相比鼻尖突出度的变化显著更低（-0.31%对-6.5%；P =.04），从而提高了PDS组移植片的长期稳定性。每组均观察到1例感染事件，未发生排斥或移位情况。
在本研究中，在CSE移植手术中使用PDS板比不使用PDS板的CSE移植手术技术难度更低，且移植片放置后鼻尖突出度的长期变化更小。
1。
clinicaltrials.gov标识符：NCT01225250。
