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EVALUATION STUDIES
JOURNAL ARTICLE
MULTICENTER STUDY
A multicenter evaluation of the safety of Gore-Tex as an implant in Asian rhinoplasty.
American Journal of Rhinology 2006 November
BACKGROUND: A retrospective multicenter study examined the safety of Gore-Tex as a nasal implant in rhinoplasty.
METHODS: This study involved 853 patients (656 primary surgeries and 197 secondary surgeries) who had undergone rhinoplasty and used Gore-Tex either at the dorsum or at the nasal tip. Data were extracted from the medical records by surgeons and entered on a standard form. Data included the information about the demographics and history of the patient, method and results of surgery, complications, follow-up, and various factors believed to predispose to complications.
RESULTS: The average follow-up period was 18 months. Overall complication rate associated with Gore-Tex was 2.5% (21 cases). Infection was the most common complication (18 cases; 2.1%) followed by two cases of seroma and one case of persistent nasal swelling. Among the 21 suffering complications, 19 patients (91%) needed graft removal. Nine cases of infection developed in primary surgeries (1.4%) and nine cases developed in secondary surgeries (4.6%), which represented a statistically higher complication rate in those undergoing secondary surgery (p = 0.0062). Infections developed within 1 month in five cases and nine cases developed infection >6 months postoperatively. Other complications including esthetic problems were identified in 16 cases (1.9%).
CONCLUSION: Gore-Tex should be used judiciously in rhinoplasty because of a 2.1% infection rate, a risk that is higher still after secondary surgery; moreover, once infected, Gore-Tex implants usually require removal.
METHODS: This study involved 853 patients (656 primary surgeries and 197 secondary surgeries) who had undergone rhinoplasty and used Gore-Tex either at the dorsum or at the nasal tip. Data were extracted from the medical records by surgeons and entered on a standard form. Data included the information about the demographics and history of the patient, method and results of surgery, complications, follow-up, and various factors believed to predispose to complications.
RESULTS: The average follow-up period was 18 months. Overall complication rate associated with Gore-Tex was 2.5% (21 cases). Infection was the most common complication (18 cases; 2.1%) followed by two cases of seroma and one case of persistent nasal swelling. Among the 21 suffering complications, 19 patients (91%) needed graft removal. Nine cases of infection developed in primary surgeries (1.4%) and nine cases developed in secondary surgeries (4.6%), which represented a statistically higher complication rate in those undergoing secondary surgery (p = 0.0062). Infections developed within 1 month in five cases and nine cases developed infection >6 months postoperatively. Other complications including esthetic problems were identified in 16 cases (1.9%).
CONCLUSION: Gore-Tex should be used judiciously in rhinoplasty because of a 2.1% infection rate, a risk that is higher still after secondary surgery; moreover, once infected, Gore-Tex implants usually require removal.
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