Platelet gummi candy effect on the Oral cavity resistant GVHD wounds
Phase 1
- Conditions
- Oral cavity GVHD wounds.Chronic graft-versus-host diseaseD89.811
- Registration Number
- IRCT20201202049568N4
- Lead Sponsor
- Omid charity
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
The patient has GVHD after allogeneic hematopoietic stem cell transplantation
At least 100 days must have passed since the patient was transplanted
Age range between 2 to 12 years
Exclusion Criteria
Other systemic disorders such as severe cardiovascular diseases
Patients who had lesions with dysplasia
Patients who received topical treatments in the last 2 weeks
Patients receiving therapy with anticoagulants
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound size, amount of pain and burning in the mouth. Timepoint: 3 Months. Method of measurement: Direct wound observation , Numerical Rating score of Pain, graded from 0 to 10, were 0 is no pain at all and 10 represent severe pain, obtaining lower values reflects improvement.
- Secondary Outcome Measures
Name Time Method Remission time. Timepoint: 3 months. Method of measurement: Time until flare up of the disease occur using a binary scale (Stable/Not stable) described by Conrotto et al., 2006.