Trial | NCT01440725  Report issue

Title

Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma
Multicenter Double Blind, With Evaluator Blinding, Parallel, Randomized Clinical Trial, to Assess the Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    platelet-rich plasma ...

  • Study Participants

    71
This is a multicenter, simple blind, masking of outcomes assessors, parallel, randomised clinical trial in patient with muscle rupture and with hematoma production. The main hypothesis is that infiltration in the area of muscle injury in autologous platelet-rich plasma (PRP)improves muscle regeneration and repair by shortening the time to complete recovery.

The main objective is to evaluate the PRP for healing muscular lesions 'tennis leg' type or distal rectus femoral. The secondary objectives are: to evaluate the risk of lesion recurrence; to evaluate the quality of lesion recovery process and evaluate intervention's safety.

Experimental treatment will be the administration of PRP autologous (4-8 cc in a unique dose) by muscular infiltration en the empty space generated after the hematoma evacuation. Control treatment will be hematoma evacuation. Both treatment groups will use compressive bandage and they will recommend rest, extremity elevation, local ice and lately physiotherapy.

Size sample: 76 patients (38 in each group)
Study Started
Oct 31
2009
Primary Completion
Dec 31
2012
Study Completion
Dec 31
2012
Last Update
Jan 10
2013
Estimate

Biological Autologous Platelet-rich plasma (PRP)

4-8cc, a single dose

  • Other names: Platelet-rich plasma, Growth factors from platelet-rich plasma

Procedure Evacuation of haematoma

Evacuation of the haematoma, a single procedure

  • Other names: Drainage of haematoma

PRP Experimental

Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma.

Evacuation of haematoma Active Comparator

Evacuation of the hematoma, and simulation of the administration of PRP

Criteria 

Inclusion Criteria:

Adults over 18 years
Lesion with haematoma at the Gastrocnemius muscle or the lower portion of the rectus femoral muscle
Acceptance to participate at the clinical trial
Not indicated the surgical treatment of the muscle injury

Exclusion criteria

Patients who do not meet the inclusion criteria
History of bleeding disorders
Inability to follow-up the patient
The use of corticosteroids, acetylsalicylic acid(Aspirin ®) and nonsteroidal antiinflammatory drugs during the study
No Results Posted