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

El-Mowafi, Hani; Araby, Ahmed El; Kandil, Yasser; Zaghloul, Ahmed

doi:10.1002/rth2.12049

Cited by 4 publications

(1 citation statement)

References 22 publications

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“…Orthopaedic surgical or traumatic injuries are often accompanied with impressive superficial symptoms that include vascular disorders (ecchymoses and subdermal hematomas), oedema and pain, as a common result of a physical trauma. Topical applications are frequently used to treat subdermal hematomas and consequent symptoms, and include anti-inflammatory and antioedematous treatments like heparin and/or other mucopolysaccharide gels and creams [8]. The present study confirmed that topical heparin is able to control these superficial symptoms.…”

Section: Resultssupporting

confidence: 83%

The Efficacy of Topical Heparin Preparations for the Management of Pain and Superficial Vascular Disorders in Orthopaedic Surgery and Musculoskeletal Trauma

HOZAN¹

2022

FARMACIA

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Superficial symptoms (oedema, inflammation, hematoma) following musculoskeletal trauma or orthopaedic interventions are more difficult to resolve when the prescription includes heparin and nonsteroidal anti-inflammatory drugs only for systemic administration. That is why treatment prescription often includes also preparations with heparin for topical administration, available on the market in various concentrations and combinations. The present study aimed to evaluate comparatively and in clinical conditions the efficacy and safety of three topical preparations with heparin: a gel with heparin 1000 IU/g, a gel with heparin 500 IU/g and penetration enhancers (dexpanthenol and allantoin) and a gel with 500 IU/g heparin in combination with diclofenac 10 mg/g and a penetration enhancer (dexpanthenol). The study group consisted of 199 patients treated in the Orthopaedics and Traumatology department for musculoskeletal injuries or with orthopaedic surgeries assigned in 3 groups corresponding to each topical preparation studied. At inclusion and then after 3, 7 and 14 days of treatment, the following parameters were evaluated: spontaneous pain, pain on active movement, pain on passive movement (using a VAS scale 0 -10), hematoma area (cm 2 ) and inflamed area (cm 2 ). The results show that the heparin gel 500 IU/g in combination with diclofenac 10 mg/g and a penetration enhancer (dexpanthenol) was the most effective in relieving the investigated symptoms, since it reported the largest differences in improvement from baseline even after 7 days of treatment. The highest difference from baseline was obtained for hematoma area and for inflamed area. All three topical preparations were well tolerated. The conclusion of the study is that topical administration of the combination of heparin and diclofenac together with penetration enhancers controls better and faster post-traumatic or post-surgical superficial symptoms, and the addition of this type of preparation in the post-traumatic treatment regimen brings a definite benefit for patient. RezumatSimptomele superficiale (edem, inflamație, hematom) consecutive traumatismelor musculoscheletice sau intervențiilor ortopedice se remit mai greu atunci cand prescripția medicală include heparină și antiinflamatoare nesteroidiene doar pentru administrare sistemică. Studiul de față și-a propus să evalueze comparativ și în condiții clinice eficacitatea și siguranța a trei preparate topice cu heparină: un gel cu heparină 1000 UI/g, un gel cu heparină 500 UI/g și promotori de absorbție (dexpantenol și alantoină) și un gel cu heparină 500 UI/g în combinație cu diclofenac 10 mg/g și promotor de absorbție (dexpantenol). Lotul de studiu a fost alcătuit din 199 de pacienți tratați în clinica de Ortopedie și Traumatologie pentru traumatisme musculoscheletice sau cu intervenții chirugicale ortopedice alocați în 3 grupe corespunzătoare fiecărui preparat topic studiat. La includere și apoi după 3, 7 și 14 zile de tratament au fost evaluați următorii parametri: durerea spontană, durerea la mișcare...

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Section: Resultssupporting

confidence: 83%

The Efficacy of Topical Heparin Preparations for the Management of Pain and Superficial Vascular Disorders in Orthopaedic Surgery and Musculoskeletal Trauma

HOZAN¹

2022

FARMACIA

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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

El-Mowafi

Araby

Kandil

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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Essentials Efficacy and safety data on recombinant hirudin gels for the treatment of hematomas is limited.We assessed the clinical efficacy of a topical r‐hirudin gel in 199 patients with hematomas.Treated patients exhibited significant reductions in hematoma size and flare within 16 days.r‐hirudin gel treatment induces a complete resolution of hematomas and associated edema in 98%, and 99% of patients, respectively. BackgroundHirudin is the most potent direct thrombin inhibitor, and recombinant forms are routinely used in anticoagulation therapy. Recombinant hirudin gels are commercially available for the treatment of hematomas and associated symptoms.ObjectivesTo assess the efficacy and safety of a topically administered recombinant hirudin gel in patients with hematomas.Patients/MethodsThis double‐blind, placebo‐controlled, phase IV investigation recruited patients presenting with at least one hematoma. Subjects were randomly assigned (1:1) recombinant hirudin gel (1120 IU/100 g) or a placebo, administered 2‐3 times daily for 16 days. Changes in hematoma size, flare, and the proportion of patients achieving complete resolution of hematomas and associated edemas were investigated.ResultsBy study end, a greater proportion of subjects in the treatment group achieved a complete resolution of hematomas versus placebo (98.0% vs 71.9%; P < .001) and edemas (99% vs 50%; P < .001). Patients in the recombinant hirudin group exhibited a marginally larger, yet significant, reduction in mean hematoma size versus placebo (99.9% vs 96.6%; P < .001) and flare (93.6% vs 78.6%; P < .001). Median time to hematoma resolution for the recombinant hirudin and placebo administered cohorts was 8 and 16 days, respectively (P < .001). No adverse events were reported for the recombinant hirudin cohort.ConclusionsTopical recombinant hirudin is an effective, safe, and well tolerated intervention for the symptomatic treatment of hematomas. This trial was registered at http://www.clinicaltrials.gov as NCT01960569.

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Hormones, Blood Products, and Therapeutic Enzymes

Silva

Costa

Almeida

et al. 2019

Current Applications of Pharmaceutical Biotechnology

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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

Cited by 4 publications

References 22 publications

The Efficacy of Topical Heparin Preparations for the Management of Pain and Superficial Vascular Disorders in Orthopaedic Surgery and Musculoskeletal Trauma

The Efficacy of Topical Heparin Preparations for the Management of Pain and Superficial Vascular Disorders in Orthopaedic Surgery and Musculoskeletal Trauma

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

Hormones, Blood Products, and Therapeutic Enzymes

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