Comparing the Efficacy of Tisseel versus Surgicel as a Hemostatic Agent in Cleft Palate Surgery: A Randomized Controlled Trial.

Abstract

Purpose: The purpose of this randomized clinical trial is to compare the efficacy of Tisseel (fibrin glue) with Surgicel as a hemostatic agent in cleft palate surgery.

Methods: This prospective randomized clinical trial consists of 22 patients consenting to the study, and they were randomly allocated to Surgicel (Group 1) and Tisseel (fibrin glue-Group 2), with 11 patients in each. It was a parallel-group clinical trial with balanced randomization (1:1). Patients reported to Meenakshi cleft and craniofacial center for cleft palate surgery were included in this study. The primary outcome measures of this study were to assess the bleeding (intraoperative-bleeding scale) and healing in periodic intervals (healing chart).

Results: This study includes 22 patients, of which 8 were bilateral cleft palate and 14 were unilateral cleft palate. The maximum width of the cleft at the level of hard and soft palate recorded was 1.5 cm and 1.8 cm, respectively. On comparing the bleeding scales among the two groups, the differences were said to be statistically significant (p = 0.011). There were 2 reported cases of palatal fistula in Surgicel group I in the 9th and 13th month of follow-up. Our study occurrence of palatal fistula ranged 4.5% in the Surgicel group and 0% in the Tisseel group.

Conclusion: By comparing bleeding and wound healing in primary palate repair defects, the Tisseel group patients significantly showed better results compared to the Surgicel group. The tolerance to Tisseel was also evident by the way of reduced inflammation and less complications in that group.