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IRCT20201007048955N1 IRCT 2020-10-11 Clinical Research Development Center Efficacy of autologous platelet rich plasma (PRP) in prevention of hypertrophic scar Evaluation the efficacy of autologous platelet rich plasma (PRP) in prevention of hypertrophic scar at the site of sternotomy in adults with open heart surgery in Shahid Modarres Hospital in 2020-2021 2020-11-21 anticipated 50 Complete https://irct.ir/trial/51485 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Used, Assignment: Single, Purpose: Prevention, Blinding description: The patients' wound at the site of mid-sternotomy is divided into upper and lower parts, then 4 cc of PRP is randomly injected in one part and 4 cc of normal saline as placebo in the other part. Patients' wounds are then assessed at 2nd, 12th and 24th weeks after surgery by another person who does not know the injection site of PRP and placebo , and the hypertrophic scars in both areas is evaluated by using the Vancouver scar scale(VSS). N/A Keloid and hypertrophic scar. Intervention group: Before the surgery and injection of anesthetics and anticoagulants, a certain volume of blood is taken from the patient .PRP is prepared by an educated person with the help of a standard kit. The midsternal wound is divided into two parts. Randomly, PRP is injected into one half and normal saline solution in the other half as a placebo. Thus every patient himself is considered as control too. The scar formed at the wound site will be assessed at 2nd, 12th and 24th weeks after the surgery by an educated person not aware of the site of the PRP injection.. No - There is not a plan to make this available Justification or reason for not sharing IPD is In order to protect the patients' personal information, the participants' data cannot be revealed.
public Sadra Ashrafi
ُSchool of medicine, Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Tabnak St., Evin, Shaheed Chamran Avenue
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 sadra.ashrafi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Zahra Ansari aval
Shahid Modarres Hospital, Above Kaj Square, Saadat Abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2208 3095 z.ansari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Not having diabetes Not having autoimmune diseases Not having thrombocytopenia(platelets below 150000) Not receiving glucocorticoids 18 years no limit Both Patient not referring to the doctor for surveillance Death of the patient during the surveillance period Prevention Intervention group: Before the surgery and injection of anesthetics and anticoagulants, a certain volume of blood is taken from the patient .PRP is prepared by an educated person with the help of a standard kit. The midsternal wound is divided into two parts. Randomly, PRP is injected into one half and normal saline solution in the other half as a placebo. Thus every patient himself is considered as control too. The scar formed at the wound site will be assessed at 2nd, 12th and 24th weeks after the surgery by an educated person not aware of the site of the PRP injection. Hypertrophic scar score. Timepoint: 2nd, 12th and 24th weeks after surgery. Method of measurement: Vancouver scar scale(VSS). Clinical Research Development Center Approved 2019-02-26 Ethics committee of Shahid Beheshti University of Medical Sciences Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital,Tabnak St. , Evin, Shaheed Chamran Highway Tehran Tehran Iran (Islamic Republic of)