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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 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

    • 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 h
    Sponsor: MinaPharm Pharmaceuticals

    Current Primary Outcome:

    • Size of haematoma [ Time Frame: 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 [ Time Frame: 6 months ]
      Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm).
    • Severity of Pain [ Time Frame: 6 months ]
      Assessment of pain severity will be by Vas score
    • Change in Colour [ Time Frame: 6 months ]
      Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: MinaPharm Pharmaceuticals

    Dates:
    Date Received: October 7, 2013
    Date Started: October 2013
    Date Completion: April 2014
    Last Updated: October 9, 2013
    Last Verified: October 2013