A Phase 3 interventional study of Autologous Platelet-rich plasma (PRP) and Evacuation of haematoma in Muscle Injuries, sponsored by Institut de Terapia Regenerativa Tissular. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-10.
Sponsored by Institut de Terapia Regenerativa Tissular · Phase 3, Interventional, and Treatment
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)
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's enrollment of 71 is close to the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Institut de Terapia Regenerativa Tissular is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma.
Biological: Autologous Platelet-rich plasma (PRP)
Evacuation of the hematoma, and simulation of the administration of PRP
Procedure: Evacuation of haematoma
4-8cc, a single dose
Also known as: Platelet-rich plasma, Growth factors from platelet-rich plasma
Evacuation of the haematoma, a single procedure
Also known as: Drainage of haematoma
Time to complete recover of muscular lesions
The complete recovering will be when the patient does his habitual activity.
Time frame: weekely assessment during 8 weeks
Percentage of muscular lesion recurrence.
Percentage of patients with muscular lesion recurrence. Muscular lesion recurrence will be considered if there are symptoms and a lesion gap by ultra sound scan.
Time frame: During all study (one year of follow-up)
Percentage of healing
Percentage of patients with the healed lesion
Time frame: 8 weeks
Quality of the regenerated area
By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)
Time frame: at 8 week
Pain
The pain will be measured by a VAS each week, the first 8 weeks of the study and, at 6 and 12 month.
Time frame: 12 months
Adverse effects to treatments
Adverse effects will be assessed each week, the first 8 weeks of the study and, at 6 and 12 month.
Time frame: 12 months
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Platelet rich plasma
Institut de Terapia Regenerativa Tissular