A randomized controlled trial of Velcro versus standard twill ties following pediatric tracheotomy

Objectives/Hypothesis: Tracheotomy is a common procedure. A reliable method of securing the tracheotomy tube is essential to minimize accidental decannulation. However, skin breakdown has been reported in ∼30% of patients. We sought to evaluate rates of skin-related complications and accidental decannulation with the use of Velcro ties compared to twill ties. Study Design: A nonblinded, randomized controlled trial comparing Velcro versus twill ties in patients undergoing tracheotomy between July 1, 2014 and January 31, 2016. Methods: Patients ≤21 years of age were recruited and randomized to receive either Velcro or twill ties. The primary outcome measure was skin-related complications. The secondary outcome measure was accidental decannulation. Outcome measures were followed through postoperative day 5. Results: Ninety-three patients were eligible, and 63 were enrolled. No patients were withdrawn. Fifty-seven patients were included in the analysis. Twenty-seven (47.4%) received Velcro, and 30 (52.6%) received twill. Five enrolled patients did not undergo tracheotomy (one Velcro, four twill). One was diagnosed with a genetic skin condition after enrollment but prior to undergoing tracheotomy. Patient characteristics were similar between groups. No significant differences were found with respect to skin-related complications (P = .59). Six patients (20%) with twill ties required early tie change compared to two (7.4%) with Velcro ties (P = .5). Two accidental decannulations oc