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.
This study aims to demonstrate the non-inferior efficacy of a compound Staphylococcal lysostaphin mouthrinse (Xinjingjie Mouthrinse®) to that of chlorhexidine mouthrinse in reducing OM occurrence in patients receiving myeloablative conditioning allo-HSCT. It also seeks to observe patient treatment adherence and pain, so as to provide evidence for the appropriate OM prevention and management measures in clinical practice. This randomized, controlled, non-inferiority clinical trial was conducted at the Bone Marrow Transplant Center, the First Affiliated Hospital of Medical College, Zhejiang University from January 2020 to December 2021.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
388
Lysostaphin is a proteolytic enzyme produced by a specific species of Staphylococcus, uniquely capable of cleaving the cross-linking pentaglycine bridges within the cell walls of Staphylococcus aureus.
Chlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM.
Bone marrow transplantation center, the First Affiliated Hospital of Medical College, Zhejiang University, Hangzhou, China
Hangzhou, Zhejiang, China
cumulative incidence of oral mucositis
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
severity of oral mucositis
The severity of OM was assessed according to the WHO grading criteria.
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
the onset time of oral mucositis
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
oral pain
Oral pain was evaluated using the Numeric Rating Scale (NRS), ranging from 0 to 10, with higher numbers indicating greater pain intensity.
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
compliance with mouth rinsing
Compliance was measured by the average daily frequency of mouthrinse use.
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
the number of days new analgesics are used due to OM
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
time to neutrophil engraftment
Neutrophil engraftment was defined as three consecutive days with a neutrophil count \>0.5×10e9/L.
Time frame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
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