Study of the effect of adding samen-ista powder in controlling bleeding of superficial scalp injuries in patients referred to the emergency department

Determining the effect of adding samen-ista powder in controlling of bleeding of superficial scalp injuries in patients referred to the emergency department

In a randomized single-blind clinical trial with control and some parallel groups, phase II will be carried out on 90 patients. Randomization will be done through the sealed-envelope method using the Randomaize.com site.

After the initial steps to irrigate the wound, the patients will be randomly divided into two groups. Special codes ( A, B) will be assigned to the intervention and placebo package so that the participants are unaware of the type of treatment received.

The inclusion criteria are the age of >18 years, informed consent to participate in the study, active bleeding, and consistent vital signs. The exclusion criteria: having underlying coagulation diseases, use of anticoagulants, pregnancy, arterial bleeding, the need for additional treatment / the age of >65 years, injuries with burns (electrical, thermal, chemical burns) or crushes, having active inflammatory lesions, neoplasm, active infectious lesions (bacterial, fungal, viral, or parasitic), recent surgery on the scalp (within two weeks) or hair transplant in the last 3 months, and renal failure (ESRD).

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.

Injury dimensions (1-12 cm), scalp injury location, duration of active bleeding, reperfusion, duration of homeostasis.

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.

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.

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.

Eight to twelve months after the publication of the study results.

The researchers working in scientific centers and academic institutions.

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

Dr. Hamideh Feiz Disfani

Sending a written request to the project manager and all the researchers involved in the project