Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas

Study Overview
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Brief Summary
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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
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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 : Age of patients between 20 and 60 years old. Patients with all types of haematomas. 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. 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 ) .

Official Title
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Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas

Conditions
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r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas

Intervention / Treatment
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* Drug: active product ( Thrombexx) assigned to arm 1
* Other: Placebo assigned to arm 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 : active product (Thrombexx)<br>100 patients will have the active product(Thrombexx), their visits on days 1,4,8 and 16 for target parameters assessment | Drug: active product ( Thrombexx) assigned to arm 1<br>* Dispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete<br>* Other names: Topical r-Hirudin;|
| Placebo Comparator: Arm 2 : Placebo<br>100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment | Other: Placebo assigned to arm 2<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of haematoma | Assessment the size of haematoma will be by ruler with unit centimeter(cm) , The ruler will measure the longest 2 intersecting line. | 6 months | 
| Size of oedema | Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm). | 6 months | 
| Severity of Pain | Assessment of pain severity will be by Vas score | 6 months | 
| Change in Colour | Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombexx, Topical r-Hirudin, Efficacy, haematoma