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IRCT20210703051771N1 IRCT 2021-09-12 Mashhad University of Medical Sciences Effect of adding samen-ista powder in controlling bleeding Study of the effect of adding samen-ista powder in controlling bleeding of superficial scalp injuries in patients referred to the emergency department 2021-09-23 anticipated 90 Complete https://irct.ir/trial/57305 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sealed-envelope method is going to be used to generate a random allocation sequence. In this method, the contents of the envelopes, including random numbers, will be prepared and printed by a research team member using the Randomaize.com site and will be put inside the envelopes. They will be sealed so that their contents will not be visible from the outside. The research aim will then be explained to each person who meets the inclusion criteria, and if desired,/he will sign the informed consent and take an envelope, open it, and enter the intervention or control group based on the content of the envelope, Blinding description: In this study, participants are blinded to the intervention received based on codes (codes A and B) that people are unaware of the type of intervention received and only researchers are aware of it. 2 Open wound of the unspecified body region.. Intervention 1: Intervention Group: The intervention group will receive Samen Ista medicine, which is a 4-gram vial. The white powder is first dissolved in 25 CC of distilled water and then poured on the bleeding site within 5 to 10 seconds using a syringe. If the bleeding is not controlled within 90 seconds, the patient will undergo routine bleeding control treatments if necessary. Intervention 2: Control group: In the control group, besides routine treatments, a vial of distilled water will be poured on the wound as a placebo. Yes - There is a plan to make this available What will be shared: Because the researchers follow ethical standards, the information of all the participants will be recorded anonymously, and their informed consent on the publication of the research results will be got to avoid any problems regarding the publication of the study data. When: Eight to twelve months after the publication of the study results. To whom: The researchers working in scientific centers and academic institutions. Conditions: 1- Contributing to continue clinical research in this field 2- Using in systematic reviews 3- Performing more statistical analyzes to improve the reporting accuracy and reduce possible errors Where to obtain: Dr. Hamideh Feiz Disfani How to obtain: Sending a written request to the project manager and all the researchers involved in the project Comments:
public Hamideh Feiz Disfani
Shahid Hasheminejad hospital, Abourihan Blvd, Tollab, Mashhad city
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3273 7015 feyzh@mums.ac.ir Mashhad University of Medical Sciences scientific Hamideh Feyz Disfani
Shahid Hasheminejad hospital, Abourihan Blvd, Tollab, Mashhad city
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3273 7015 feyzh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age of >18 years Informed consent to participate in the study Active bleeding and consistent vital signs 18 years 65 years Both Having underlying coagulation diseases Use of anticoagulants Arterial bleeding Need for additional treatment Age of >65 years Injuries with burns (electrical, thermal, chemical burns) or crushes Having active inflammatory lesions Neoplasm Presence of active infectious lesions (bacterial, fungal, viral, or parasitic) Recent surgery on the scalp (within two weeks) or hair transplant in the last 3 months Renal failure (ESRD) Pregnancy T14.9 Unspecified injury Treatment - Drugs Treatment - Drugs Intervention Group: The intervention group will receive Samen Ista medicine, which is a 4-gram vial. The white powder is first dissolved in 25 CC of distilled water and then poured on the bleeding site within 5 to 10 seconds using a syringe. If the bleeding is not controlled within 90 seconds, the patient will undergo routine bleeding control treatments if necessary. Control group: In the control group, besides routine treatments, a vial of distilled water will be poured on the wound as a placebo. Injury dimensions (1-12 cm). Timepoint: It will be carried out in a 1-day period, the wound will be examined for homeostasis, and the time required for homeostasis will be recorded. Method of measurement: Measurement of Injury dimensions. Scalp injury location. Timepoint: It will be carried out in a 1-day period, the wound will be examined for hemostasis, and the time required for homeostasis will be recorded. Method of measurement: Measurement of Injury dimensions. Duration of active bleeding. Timepoint: It will be carried out in a 1-day period, the wound will be examined for hemostasis, and the time required for homeostasis will be recorded. Method of measurement: According to the duration of active bleeding. Re-perfusion. Timepoint: It will be carried out in a 1-day period, the wound will be examined for hemostasis, and the time required for homeostasis will be recorded. Method of measurement: Re-perfusion. Duration of homeostasis. Timepoint: It will be carried out in a 1-day period, the wound will be examined for hemostasis, and the time required for homeostasis will be recorded. Method of measurement: According to the duration of homeostasis. Mashhad University of Medical Sciences Approved 2021-04-27 The ethics committee of the Mashhad University of Medical Sciences. Shahid Hasheminejad hospital, Abourihan Blvd, Tollab, Mashhad city. Mashhad Razavi Khorasan Iran (Islamic Republic of)