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| ID | Type | Description | Link |
|---|---|---|---|
| ISCIII; Spain | Other Grant/Funding Number | PI080724 |
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| Name | Class |
|---|---|
| Asociacion Colaboracion Cochrane Iberoamericana | OTHER |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Platelet-rich plasma (PRP) | Biological | 4-8cc, a single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to complete recover of muscular lesions | The complete recovering will be when the patient does his habitual activity. | weekely assessment during 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During all study (one year of follow-up) |
| Percentage of healing |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Martínez Zapata, Mª José | Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau | Principal Investigator |
| Orozco Delclòs, LLuís | Institut de Teràpia Regenerativa i Tissular. Centro Médico Teknon. Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Cochrane Iberoamericano | Barcelona | Barcelona | 08041 | Spain |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Evacuation of haematoma | Procedure | Evacuation of the haematoma, a single procedure |
|
|
Percentage of patients with the healed lesion |
| 8 weeks |
| Quality of the regenerated area | By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis) | 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. | 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. | 12 months |