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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 :
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
Inclusion Criteria :
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.
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 ) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 : active product (Thrombexx) | Active Comparator | 100 patients will have the active product(Thrombexx), their visits on days 1,4,8 and 16 for target parameters assessment |
|
| Arm 2 : Placebo | Placebo Comparator | 100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active product ( Thrombexx) assigned to arm 1 | Drug | Dispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud Hafez, Professor | Contact | 002 0100 7566299 | mhafez@msn.com | |
| Moustafa Sameer, Dr | Contact | 002 0100 6016 212 | msameer@minapharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Hafez, Professor | 6th October university | Principal Investigator |
| Ahmed Moneer, Dr | 6th october university | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Mahmoud Hafez | Recruiting | Cairo | Cairo Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30046714 | Derived | El-Mowafi H, El Araby A, Kandil Y, Zaghloul A. Randomized, double-blind, placebo-controlled, interventional phase IV investigation to assess the efficacy and safety of r-hirudin gel (1120I.U) in patients with hematomas. Res Pract Thromb Haemost. 2017 Nov 6;2(1):139-146. doi: 10.1002/rth2.12049. eCollection 2018 Jan. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 19, 2017 | |
| Reset | Apr 6, 2017 | |
| Release | Apr 10, 2017 | |
| Reset | Jun 23, 2017 | |
| Release | Jul 2, 2017 | |
| Reset | Jan 30, 2018 | |
| Release | Feb 1, 2018 | |
| Reset | Oct 26, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 19, 2017 | Apr 6, 2017 | |||
| Apr 10, 2017 |
| ID | Term |
|---|---|
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo assigned to arm 2 | Other |
|
| Jun 23, 2017 |
| Jul 2, 2017 | Jan 30, 2018 |
| Feb 1, 2018 | Oct 26, 2018 |