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Study aim
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Comparative efficacy of intralesional Cryotherapy vs intralesional Corticosteroid . 5 Fluorouracil in the treatment of hypertrophic scars and keloids
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Design
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This interventional research would be conducted on patients with hypertrophic and colloid, admitted to the Skin Clinic of Sina Hospital from August 2016 to May 2017, after being approved by the Research Committee and the Ethics Committee. This research is double-blinded experimental, interventional (clinical trial) study, in which researcher and patient are not aware of the treatment method, and patients would be distinguished with manual coding.
A checklist would be prepared by the research executor and it would be completed individually by each patient. Then, the patients would be randomly assigned to three distinct groups based on random numbers table, and each stage would be evaluated by the project assistant. The number of subjects in each group would be 21. The first group would be treated with intralesional injection of cryotherapy. The second and third groups would be treated with intralesional injection of steroids and 5-fluoroacrylate, respectively. Before starting treatment, the type of scar (hypertrophic or colloid) is determined and its size is measured and it would be recorded along with the appearance characteristics, such as color, erythema, telangiectasia, and symptoms associated with the lesion.
Cryotherapy would be injected intralesionally using a special probe and freezing within the tissue. The steroid used in this research is triamcinolone 40 mg / ml and the amount of its intralesional injection would be 0.2 ml / cm². The amount of intralesional injection for 5-fluorouracil 250 ml / 5 ml would be 0.2 ml/cm². Treatment would be repeated every 4 weeks and up to 6 sessions, depending on the scar tissue. Before and after treatment, image of lesions is prepared. Scare severity is measured using the vernier scale.
In each treatment session, the size and appearance of scars are examined and recorded in the checklist.
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Settings and conduct
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This interventional research would be conducted on patients with hypertrophic and colloid, admitted to the Skin Clinic of Sina Hospital from August 2016 to May 2017, after being approved by the Research Committee and the Ethics Committee.
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Participants/Inclusion and exclusion criteria
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Patients with Hypertrophic Osteoarthritis and Osteoarthritis will be studied andThe exclusion criteria of research include pregnant and breastfeeding women, age less than 12 years, history of allergy to the drugs used in the research, patients with uncontrolled blood pressure, liver and kidney disease, immune system deficiency and reduction in blood cell levels.
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Intervention groups
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The first group would be treated with intralesional injection of cryotherapy. The second and third groups would be treated with intralesional injection of steroids and 5-fluoroacrylate, respectively
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Main outcome variables
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Scar Volume