Oronasal Fistulae Prevention With Custom-Made Palatal Shield in Children With Cleft Palate With or Without Cleft Lip: An Institutional Experience

The custom-made palatal shield is an innovative treatment modality implemented after palatoplasty, in children with cleft palate with or without cleft lip. This retrospective cohort study aims to determine the impact of the palatal shield in the prevention of oronasal fistulae (ONF) formation. A total of 67 consecutive patients treated with the palatal shield directly after palatoplasty were included in this study. Half of the patients (n=34) had a Veau IV, 33% (n=22) a Veau III and the remaining 16% (n=11) had a Veau II. The operation indication was primary palatoplasty for 25 patients, and ONF repair for 42 patients. The custom-made palatal shield was fixated to the deciduous molars using ligature wire immediately after palatoplasty. We retrospectively analyzed the outcomes of the implementation of this treatment modality, focusing on ONF incidence rate, including normal diet resumption and length of hospital stay. The ONF incidence rate was 8% (2/25 patients) in our primary palatoplasty group, and 14% (6/42 patients) in our fistula repair group. Most children (n=6, 75%) who developed an ONF presented with Veau grade IV. The median duration of the palatal shield placement was 21 (IQR: 14-23) days and the hospitalization length was <24 hours (0-1 night) for 86% (n=57) of our patients. Our custom-made palatal shield is a potentially effective, safe, and logistically readily available tool to prevent ONF formation after palatoplasty. In addition, it allows prompt normal diet resumption postoperatively, which may help shorten the hospital stay.