The Effect of Combined Use of Anti-fibrotic Agent With Platelet Rich Plasma on Skeletal Muscle Healing After Acute Injuries

Mostafa Hassanein, Msc20 enrolled

Overview

The aim of this comparative study is to determine whether or not LOSARTAN with its anti-fibrotic action has an added effect when administrated with platelet rich plasma injection on skeletal muscle healing and on decreasing the fibrous scar after muscle injuries in comparison with the sole administration of platelet rich plasma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

PRP Losartan Muscle Injury Sport Injury

Interventions

Autologous platelets rich plasmaBIOLOGICAL

30 ml of venous blood were drawn from the participant by means of venipuncture. The collected blood was mixed with 3 ml anti-coagulant acid citrate dextrose in the centrifugation sterile tube. The blood sample was then centrifuged using the centrifugation machine. 3 ml of PRP from the buffy coat layer were loaded in a 5 ml syringe. After local sterilization and draping of the site of injection and under US guidance the hematoma was aspirated from the injury site and the freshly prepared PRP was injected.

Autologous platelets rich plasma + oral LOSARTAN administrationCOMBINATION_PRODUCT

in addition to local PRP injection, 50 mg / day of LOSARTAN (Cozaar® 50 mg film-coated tablets) were administrated to the study group orally every morning from day 5 and till day 30 after injury.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult age. (18 - 40 year old). * Clinically diagnosed acute skeletal muscle injury with maximum 3 days duration and ultrasonographically confirmed grade II according to Woodhouse et al. * Understanding the study and accepting the participation Exclusion Criteria: * Any connective tissue disease (e.g. rheumatoid arthritis, systemic lupus erythematous, etc.) * Hypertension or hypotension * Diabetes mellitus * Any cardiac or pulmonary disease * NSAIDs use in less than a week prior to the beginning of the study. * Muscle injuries requiring surgical interference. * No detectable injury ultrasonographically. * Anemia * Thrombocytopenia or any platelet disorder. * Pregnancy or lactation. * Local infection

Outcomes

Primary Outcomes

ecchymosis

locally at the site of injury "present or absent"

Time frame: 1or 2 days after injury

ecchymosis

locally at the site of injury "present or absent"

Time frame: 2 weeks after injury.

ecchymosis

locally at the site of injury "present or absent"

Time frame: 1month after injury.

ecchymosis

locally at the site of injury "present or absent"

Time frame: 3 months after injury.

deformity

palpable defects at the site of injury "present or absent"

Time frame: 1 or 2 days after injury

deformity

palpable defects at the site of injury "present or absent"

Time frame: 2 weeks after injury.

deformity

palpable defects at the site of injury "present or absent"

Time frame: 1month after injury.

deformity

palpable defects at the site of injury "present or absent"

Time frame: 3 months after injury.

tenderness

at the site of injury "present or absent"

Time frame: 1 or 2 days after injury

tenderness

Data from ClinicalTrials.gov

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