Real-World Effectiveness of Gelatin-Thrombin Matrix Sealant on Blood Loss in Adolescent Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion: An Interrupted Time Series Study

Abstract

Study design: Retrospective cohort study with interrupted time series analysis.

Objective: To examine the clinical effectiveness of gelatin-thrombin matrix sealant (GTMS) on blood loss reduction after adolescent idiopathic scoliosis (AIS) surgery.

Summary of background data: The real-world effectiveness of GTMS on blood loss reduction in AIS surgery has not been determined.

Patients and methods: The medical records of patients receiving AIS surgery were retrospectively collected during a period before GTMS approval at our institution (January 22, 2010-January 21, 2015) as well as during a postintroduction period (January 22, 2015-January 22, 2020). The primary outcomes were intraoperative blood loss, drain output over 24 hours, and total blood loss (intraoperative blood loss + drain output over 24 h). Interrupted time series analysis using a segmented linear regression model was used to estimate the effect of GTMS on blood loss reduction.

Results: A total of 179 AIS patients [mean age (range): 15.4 (11-30) yr; 159 females and 20 males; 63 preintroduction patients and 116 postintroduction patients] were included. After its introduction, GTMS was used in 40% of cases. Interrupted time series analysis revealed changes of -340 mL (95% CI: -649 to -31, P = 0.03) for intraoperative blood loss, -35 mL (95% CI: -124 to 55, P = 0.44) for drain output over 24 hours, and -375 mL (95% CI: -698 to -51, P = 0.02) for total blood loss.

Conclusions: The availability of GTMS was significantly associated with reduced intraoperative and total blood loss in AIS surgery. GTMS use as needed is recommended to control intraoperative bleeding in the setting of AIS surgery.

Level of evidence: 3.