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IRCT20100720004422N7 IRCT 2019-08-15 Tabriz University of Medical Sciences Effect of autologous conditioned serum on the chronic wounds The use of dressings containing autologous conditioned serum as a new method for the treatment of chronic ulcers 2019-08-23 anticipated 30 Complete https://irct.ir/trial/41444 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method through computer-generated random numbers by an independent statistician with the allocation ratio of 1:1, Blinding description: It is not possible to blind the participants to treatment. Furthermore, the treating physicians will not blind to the treatment; however, investigators providing treatment will be different from those performing wound evaluations, and the persons responsible for clinical tests and also the statistician who will execute all the statistical analysis will be blind to study group allocation. 2-3 Chronic ulcer. Intervention 1: Intervention group: Dressing containing autologous conditioned serum that is replaced once a week for 3weeks. To prepare the autologous conditioned serum, fifty milliliters of blood will be drawn from ante-cubital vein of the patients into a blood bag and be transferred to an autoclaved centrifuge tube without anticoagulants. Blood will be incubated aseptically at 37 C° for 24 hours. After incubation the tubes will be centrifuged at 3500 rpm for 10 minutes to retrieve the autologous conditioned serum. A clinical research coordinator will educate the patients about wound care and when to return for dressing replacement. Intervention 2: Control group: Dressing containing saline normal that is replaced once a week for 3 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Seyed Kazem Shakouri
Emam Reza hospital, Golgasht Str., Azadi Ave.
Tehran Iran (Islamic Republic of) 5163995479 +98 41 3336 1928 skshakouri@gmail.com Tabriz University of Medical Sciences scientific Seyed Kazem Shakouri
Emam Reza hospital, Golgasht Str., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5163995479 +98 41 3336 1928 skshakouri@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Wagner grading of lesions 1 or 2 not healing for at least 3 months 18 years 80 years Both Wagner grading of lesions 3 or 4 Active infection of the lesion Hemorrhagic disorders Platelet disorders Major large vessel disease L99 Other disorders of skin and subcutaneous tissue in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: Dressing containing autologous conditioned serum that is replaced once a week for 3weeks. To prepare the autologous conditioned serum, fifty milliliters of blood will be drawn from ante-cubital vein of the patients into a blood bag and be transferred to an autoclaved centrifuge tube without anticoagulants. Blood will be incubated aseptically at 37 C° for 24 hours. After incubation the tubes will be centrifuged at 3500 rpm for 10 minutes to retrieve the autologous conditioned serum. A clinical research coordinator will educate the patients about wound care and when to return for dressing replacement. Control group: Dressing containing saline normal that is replaced once a week for 3 weeks Ulcer healing. Timepoint: Wound size measurement at baseline (before intervention) and 21 days after dressing. Method of measurement: Pressure Ulcer Scale for Healing Includes the extent of the wound, the presence of exudates and the appearance of the wound. Tabriz University of Medical Sciences Approved 2019-05-06 Ethics committee of Tabriz University of Medical Sciences Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)