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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| compound Staphylococcal lysostaphin mouthrinse | Experimental | Patients in the compound Staphylococcal lysostaphin mouthrinse group received OM prophylaxis by sequential gargling with 15 ml of sodium bicarbonate mouthrinse and 15 ml of compound Staphylococcal lysostaphin mouthrinse. |
|
| chlorhexidine mouthrinse | Active Comparator | The chlorhexidine mouthrinse group followed the same protocol using 15 ml of sodium bicarbonate mouthrinse and 15 ml of chlorhexidine mouthrinse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| compound Staphylococcal lysostaphin mouthrinse | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| cumulative incidence of oral mucositis | Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation). |
| Measure | Description | Time Frame |
|---|---|---|
| severity of oral mucositis | The severity of OM was assessed according to the WHO grading criteria. | Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation). |
| the onset time of oral mucositis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bone marrow transplantation center, the First Affiliated Hospital of Medical College, Zhejiang University, Hangzhou, China | Hangzhou | Zhejiang | China |
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| chlorhexidine mouthrinse | Drug | Chlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM. |
|
| 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 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 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 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 from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation). |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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