drugset / Trial / NCT06791746

Compound Staphylococcal Lysostaphin Vs. Chlorhexidine Mouthrinse for Oral Mucositis in Patients Undergoing Allo-HSCT

NCT06791746

Phase 3 Completed 388 enrolled Zhejiang University
RandomizedParallel-groupOpen-labelPrevention

Summary

Oral mucositis (OM) is a common complication in patients receiving myeloablative conditioning allogeneic hematopoietic stem cell transplantation (allo-HSCT). Chlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM, yet its use is hampered by issues like tooth discoloration, unpleasant taste, and pain on ulcerated surfaces, leading to reduced patient compliance. This study aims to demonstrate the non-inferior efficacy of a compound Staphylococcal lysostaphin mouthrinse to that of chlorhexidine mouthrinse in reducing OM occurrence in patients receiving myeloablative conditioning allo-HSCT.

Timeline

Start
2020-01-02
Primary completion
2021-12-31
Completion
2022-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chlorhexidine Small molecule 15 ml Oral
Subject Lysostaphin Protein / enzyme biologic 15 ml Oral