Conclusion: The external neck brace (ENB) is a new concept in the improvement of peristomal fixation of an automatic stoma valve (ASV), which was evaluated with a new imaging method. The addition of the ENB to the Flexiderm (FLD) and Xtrabase (XB) adhesives significantly reduced absolute mean differences between the speech and the non-speech conditions.
Objectives: After total laryngectomy, peristomal fixation problems of adhesives and stoma valves are still the main reasons for the relatively small number of patients that actually use an ASV on a daily basis. Several concepts could not prevent these fixation problems. To overcome or at least diminish these attachment problems, an ENB has been developed to support peristomal adhesives. The mechanism behind this brace is that it absorbs the high stomal pressures created during tracheoesophageal speech. In this pilot study the mechanism outlined above was objectified using 3D stereophotogrammetrical measurements.
Methods: This was a prospective clinical pilot study in a university hospital setting, involving nine laryngectomized patients. Ten 3D images were taken of all patients using stereophotogrammetry; five pictures during a moment of speech and five during a non-speech condition. Two different peristomal adhesives were used during these two conditions: the Provox Flexiderm (FLD) adhesive and the Provox Xtrabase (XB) adhesive, both with and without the addition of the ENB. Besides these four combinations, a final fifth set-up using all the components (FLD + XB-ring + ENB) was added. Absolute mean differences were compared between two photographs of the area of interest, which is covered by the adhesive for all five different set-ups mentioned above. This was done during speech and non-speech conditions.
Results: Absolute mean differences at the region of the base plate between speech and non-speech conditions were most obvious while using just the FLD adhesive (4.70 mm). The use of the ENB significantly reduced the absolute mean difference to 0.58 mm (p < 0.02). The suggested set-up with a basis of the FLD adhesive combined with the solid ring extracted from the XB adhesive and the ENB showed the smallest absolute mean difference of 0.38 mm between speech and non-speech conditions (p < 0.025).