A Systematic Review of the Efficacy of Haemostatic Interventions in Primary Cleft Palate Repair

Abstract

Objective To evaluate the effectiveness of adrenaline infiltration, topical adrenaline, systemic tranexamic acid, fibrin tissue sealants and alginate-based topical coagulants at reducing blood loss and post-operative bleeding in primary cleft palate repair. Design Systematic review according to PRISMA-P guidelines, using Covidence systematic review software to facilitate 3-stage screening and data extraction by two reviewers. Setting Academic cleft surgery center. Interventions Any peri-operative intervention to reduce intra-operative and post-operative bleeding. Main Outcome Measures Estimated blood loss, rate of post-operative bleeding, rate of return to theatre for haemostasis. Results Sixteen relevant studies were identified, with a total of 1469 study participants. Nine studies examined efficacy of infiltrating vasoconstrictors and all concluded that 1:100,000–1:400,000 adrenaline infiltration reduced intra-operative blood loss, to the range of 12-60 ml. Secondary bleeding and re-operation for haemostasis were uncommon. Tranexamic acid was studied in five randomised controlled trials, two of which demonstrated a significant reduction in blood loss compared to a control group. Use of fibrin and gelatin sponge products was examined in 3 studies, all of which reported no or minimal bleeding, but did not have quantifiable outcome measures. Conclusions Infiltration with vasoconstricting agents, administration of systemic tranexamic acid and application of fibrin sealants have a well-studied and favorable safety profile in pediatric cases, and likely contribute to the relatively low incidence of post-operative bleeding and intra-operative blood loss in primary cleft palate repair.