The Effect of Using Hydroxyapatite Mesh on the Occurrence of Fistula in Patients Undergoing Primary Palatoplasty by the Sommerlad Intravelar Veloplasty: A Randomized Clinical Trial; [رثاهدافتسازاشمتیتاپآیسکوردیهربزوربلوتسیفردنارامیبرارقهتفرگتحتلمعیتسالپوتالاپهیلوااب کینکتیتسالپولورالوارتنیا:دلرماسکیییامزآراکنیلابیهدشیفداصت] Publisher

Summary: Can a mesh reduce fistulas after cleft-palate repair? A small randomized trial reported fewer later fistulas with hydroxyapatite mesh; replication is needed. #CleftPalate #Surgery

Abdali H ; Golshani M ; Fasahat A ; Poursamar S A ; Abedian M
Source: Journal of Isfahan Medical School Published:2026

Abstract

Background: Cleft lip and palate is known as one of the most common congenital malformations. This study evaluates the effect of using hydroxyapatite in primary microscopic palatoplasty to prevent postoperative fistula. Methods: This randomized, double-blind clinical trial was conducted from 2023 to 2024 at the Cleft Lip and Palate Center of Isfahan University of Medical Sciences. The surgical technique of intravalvar Somerlad valvuloplasty included separation of the oral and nasal mucosa and then repair of the nasal mucosa. In the intervention group, a hydroxyapatite mesh was placed on the nasal mucosa of the patients and then the oral mucosa was repaired. The patients were then followed up at 3 and 6 months after surgery to assess the incidence of fistula. Findings: At the first follow-up, the incidence of fistula was higher in the no-mesh group (18.8%) than in the mesh group (3.1%) (P = 0.104). However, the incidence of fistula at the second follow-up did not show a significant difference between the two groups (34.4% vs. 6.2%) (P = 0.011). From the first follow-up to the second follow-up, the incidence of fistula in the non-mesh group increased slightly (from 18.8% to 34.4%) (P = 0.063). However, in the mesh group, the incidence of fistula did not show a significant increase from the first follow-up to the second follow-up (from 3.1% to 6.2%) (P = 0.999). Conclusion: The use of hydroxyapatite mesh in primary palatoplasty has the potential to significantly reduce the incidence of postoperative fistula. © 2026, Isfahan University of Medical Sciences(IUMS). All rights reserved.