BACKGROUND: Lifetime elongation of the silicone voice rubber prostheses by inhibition of biofilm formation is a primary objective in voice restoration of laryngectomized patients. This systematic review sought to explore the existing strategies in this direction.
METHODS: We conducted a systematic search of both in vitro and in vivo literature published in PubMed, Scopus, and Cochrane Central Register of Controlled Trials, until December 31, 2022, for published and unpublished trials assessing the strategies for inhibiting biofilm formation on silicone rubber voice prostheses, and appraised quality assessment with the modified Consolidated Standards of Reporting Trials tool. We analyzed the infection prevention capacity of the included antibacterial and antifungal agents.
RESULTS: The qualitative synthesis showed that both surface modification methods and prophylactic treatment of silicone rubber voice prostheses present adequate antibiofilm activity. Of note, the majority of the suggested prosthetic surfaces were not chronically exposed to both human fluids and biofilm-forming microorganisms.
CONCLUSIONS: Various experimental methods provide promising antibiofilm activity and, thus, possible lifespan elongation of silicone rubber voice prostheses.

Tracheoesophageal puncture (TEP) is considered the gold standard for voice rehabilitation after total laryngectomy. One of the main causes of treatment failure, and a potentially serious complication, is the TEP enlargement and/or leakage around the voice prosthesis. The injection of biocompatible material to increase the volume of the puncture surrounding tissue has been studied as a popular option for conservative treatment of enlarged tracheoesophageal fistula. The aim of this paper was to perform a systematic review of the efficacy and safety of such treatment.
Search conducted in PubMed/MEDLINE, the Cochrane Library, Google Scholar, Scielo and Web of Science and through the meta-searcher Trip Database based on Preferred Reporting Items for a Systematic Review and Meta-analysis (PRISMA) statement.
Human experiments published in peer-reviewed journals, where investigators assessed the use of peri-fistular tissue augmentation for periprosthetic leakage were evaluated.
Laryngectomized patients with voice prosthesis, presenting periprosthetik leak due to enlarged fistula.
mean-duration without new leak.
A total of 196 peri-fistular tissue augmentation procedures in 97 patients were found in the 15 selected articles. The 58.8% of patients had a time without periprosthetic leak after treatment of >6 months. The 88.7% of tissue augmentation treatments resulted in periprosthetic leakage cessation. The general level of evidence of the studies included in this review was low.
Tissue augmentation treatment is a minimally invasive, biocompatible and safe solution that temporarily resolves periprosthetic leaks in many cases. There is no standard technique or material, and treatment needs to be individualised according to the experience of the practitioner and the characteristics of the patient. Future randomised studies are needed to confirm these results.

UNASSIGNED: To conduct a systematic review of the use and results of the Provox®VegaTMXtraSealTM in the prevention of periprosthetic leakage and to propose a management protocol for this voice prosthesis.
UNASSIGNED: Systematic search based on the PRISMA Statement during February 2020. Keywords were double flange, periprosthetic leakage, voice prosthesis, and laryngectomy.
UNASSIGNED: Four articles with 315 voice prosthesis (94 XtraSeal and 221 controls) in 55 patients were found. The XtraSeal mean duration was 114.28 ± 73.2 (CI 95%, 98.29-130.26) days compared to 102.98 ± 17.74 (CI 95%, 100.62-105.35) days of the control group. Out of 266 replacements, endoprosthetic leakage was the most frequent cause in both groups (62.41%). Periprosthetic leaks were less frequent in the XtraSeal (9.62%) than in the control group (22.43%).
UNASSIGNED: The XtraSeal could be effective in preventing periprosthetic leakage and lengthening the time between replacements. Studies with a robust methodology are necessary to confirm these results. Managing voice prosthesis is complex and requires a multidisciplinary and systematic approach by experienced professionals to reduce replacements and complications. Incorrect placement of the XtraSeal could cause a foreign body reaction and consequently inflammation, extrusion, or pressure lesions. The Tower of Hercules protocol: (1) Measurement of the tracheoesophageal fistula using the Provox® Measure, (2) Minimization of XtraSeal slack by avoiding the complete visualization of the prosthesis\' blue ring, (3) Nasofibroscopic examination of the oesophageal wall confirming both flanges are in correct position; could prevent or minimize complications derived from the use of the XtraSeal.

BACKGROUND: Biofilm formation on voice prostheses is the primary reason for their premature implant dysfunction. Multiple strategies have been proposed over the last decades to achieve inhibition of biofilm formation on these devices. The purpose of this study was to assess the results of the available in vitro biofilm inhibition modalities on silicone rubber voice prostheses.
METHODS: We conducted a systematic search in PubMed, Embase, and the Cochrane Central Register of Controlled Trials databases up to February 29, 2020. A total of 33 in vitro laboratory studies investigating the efficacy of different coating methods against Candida, Staphylococcus, Streptococcus, Lactobacilli, and Rothia biofilm growth on silicone rubber medical devices were included. Subgroup analysis linked to the type of prevention modality was carried out, and quality assessment was performed with the use of the modified CONSORT tool.
RESULTS: Data from 33 studies were included in qualitative analysis, of which 12 qualified for quantitative analysis. For yeast biofilm formation assessment, there was a statistically significant difference in favor of the intervention group (standardized mean difference [SMD] = -1.20; 95% confidence interval [CI] [-1.73, -0.66]; p < 0.0001). Subgroup analysis showed that combined methods (active and passive surface modification) are the most effective for biofilm inhibition in yeast (SMD = -2.53; 95% CI [-4.02, -1.03]; p = 0.00001). No statistically significant differences between intervention and control groups were shown for bacterial biofilm inhibition (SMD = -0.09; 95% CI [-0.68, 0.46]; p = 0.65), and the results from the subgroup analysis found no notable differences between the surface modification methods. After analyzing data on polymicrobial biofilms, a statistically significant difference in favor of prevention methods in comparison with the control group was detected (SMD = -2.59; 95% CI [-7.48, 2.31]; p = 0.30).
CONCLUSIONS: The meta-analysis on biofilm inhibition demonstrated significant differences in favor of yeast biofilm inhibition compared to bacteria. A stronger inhibition with the application of passive or combined active and passive surface modification techniques was reported.

Tracheoesophageal voice puncture (TEP) coupled with the use of voice prosthesis has been considered as the gold standard for speech rehabilitation in patients of advanced laryngeal/hypopharyngeal carcinomas, who have undergone a total laryngectomy with or without partial pharyngectomy. Although prosthetic voice rehabilitation is commonly practiced worldwide including India, there is a paucity of published Indian data, more so in the current era of organ conservation. This study included 60 laryngectomized patients with a prosthetic voice rehabilitation at a tertiary cancer center in South India between January 1, 2010 and December 31, 2013. Among the 60 patients, the primary site of cancer was the larynx in 43 patients and hypopharynx in the remaining 17. All patients had undergone a primary TEP insertion, 55 in the upfront setting and five in the salvage (post-radiation/chemo-radiation) setting. The ability to retain a successful trachea-esophageal speech on follow-up (median 15.5 months) in our series was around 82%. The mean device life of voice prosthesis in our patient cohort was 16 months. There was surprisingly no significant difference in the prosthesis device life on correlation with age, co-morbidities, habitat, literacy status, pre-operative tracheostomy, setting of surgery, and the extent of surgery. Our series has successfully demonstrated the safety and feasibility of using primary TEP coupled with the use of voice prosthesis for voice rehabilitation in properly selected and motivated patients of advanced laryngeal and hypopharyngeal carcinomas across all clinical settings. A mean device life of 16 months makes prosthetic voice rehabilitation, an attractive as well as a financially viable option for patients in a resource constrained setting.

OBJECTIVE: Tracheoesophageal (TE) prosthetic voice is one of the voice restoration options for individuals who have undergone a total laryngectomy. Aerodynamic analysis of the TE voice provides insight into the physiological changes that occur at the level of the neoglottis with voice prosthesis in situ. The present study is a systematic review and meta-analysis of sub-neoglottic pressure (SNP) measurement in TE speakers by direct and indirect methods.
METHODS: The screening of abstracts and titles was carried out for inclusion of articles using 10 electronic databases spanning the period from 1979 to 2016. Ten articles which met the inclusion criteria were considered for meta-analysis with a pooled age range of 40-83 years.
RESULTS: The pooled mean SNP obtained from the direct measurement method was 53.80 cm H2O with a 95% confidence interval of 21.14-86.46 cm H2O, while for the indirect measurement method, the mean SNP was 23.55 cm H2O with a 95% confidence interval of 19.23-27.87 cm H2O.
CONCLUSIONS: Based on the literature review, the various procedures followed for direct and indirect measurements of SNP contributed to a range of differences in outcome measures. The meta-analysis revealed that the \"interpolation method\" for indirect estimation of SNP was the most acceptable and valid method in TE speakers.

BACKGROUND: Tracheoesophageal puncture represents the \'gold standard\' for voice restoration following laryngectomy. Tracheoesophageal puncture can be undertaken primarily during laryngectomy or in a separate secondary procedure. There is no current consensus on which approach is superior. The current evidence comparing primary and secondary tracheoesophageal puncture was assessed.
METHODS: A systematic review and meta-analysis of articles comparing outcomes for primary and secondary tracheoesophageal puncture after laryngectomy were conducted. Outcome measures were: voice success, overall complication rate and pharyngocutaneous fistula rate.
RESULTS: Eleven case series met the inclusion criteria, two prospective and nine retrospective. Meta-analysis did not demonstrate statistically significant differences in overall complication rate or voice outcomes, though it suggested a significantly increased risk of pharyngocutaneous fistula in primary compared to secondary tracheoesophageal puncture.
CONCLUSIONS: Primary tracheoesophageal puncture is a safe and efficient approach for voice rehabilitation. However, secondary tracheoesophageal puncture should be preferred where there is a higher risk of pharyngocutaneous fistula.