r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas
Conditions
Keywords
Thrombexx, Topical r-Hirudin, Efficacy, haematoma
Brief summary
Single centre ,Phase IV , interventional, The study includes : 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo . The patients will be randomized to the active product (arm 1) or to placebo (arm 2). The study consists of 4 visits as the following : * Visit 1 : on day 1 to check patient eligibility and also for randomization . * Visit 2 : on day 4 to assess target parameters * Visit 3 : on day 8 to assess target parameters * Visit 4 : on day 16 to assess target parameters
Detailed description
Single centre ,Phase IV , interventional, The study includes : \* 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo . The patients will be randomized to the active product (arm 1) or to placebo (arm 2). The study consists of 4 visits as the following : * Visit 1 : on day 1 to check patient eligibility and also for randomization . * Visit 2 : on day 4 to assess target parameters * Visit 3 : on day 8 to assess target parameters * Visit 4 : on day 16 to assess target parameters * Study objective :Assessment the Efficacy of Topical r-Hirudin in treatment of haematomas ,also in resolving of the associated oedema * Study duration : 6 months * Selection of trial subjects: Inclusion Criteria : 1. Age of patients between 20 and 60 years old. 2. Patients with all types of haematomas. Exclusion Criteria: 1. Presence of infected wound requiring hospitalization or surgical intervention. 2. History of allergy or hypersensitivity to any of the ingredients. 3. Patients with coagulation disorders like haemophilia. 4. Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid . 5. Patients who are taking digestive enzymes like alfa chemotrypsin. * Target parameters : 1.Size of haematoma.( Measured by ruler) , The ruler will measure the longest 2 intersecting line. 2.Size of oedema : by measurement of oedema circumference 3.Pain (by Vas score). 4.Change in colour ( by colour grade scale ) .
Interventions
DRUGactive product ( Thrombexx) assigned to arm 1
Dispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete
OTHERPlacebo assigned to arm 2
Sponsors
MinaPharm Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age of patients between 20 and 60 years old. * Patients with all types of haematoma.
Exclusion criteria
* Presence of infected wound requiring hospitalization or surgical intervention. * History of allergy or hypersensitivity to any of the ingredients. * Patients with coagulation disorders like haemophilia. * Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid . * Patients who are taking digestive enzymes like alfa chemotrypsin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size of haematoma | 6 months | Assessment the size of haematoma will be by ruler with unit centimeter(cm) , The ruler will measure the longest 2 intersecting line. |
| Size of oedema | 6 months | Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm). |
| Severity of Pain | 6 months | Assessment of pain severity will be by Vas score |
| Change in Colour | 6 months | Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint |
Countries
Egypt
Contacts
Primary ContactMahmoud Hafez, Professor
Backup ContactMoustafa Sameer, Dr
Outcome results
None listed