Preparation of Nano fiber Containing Pagaze (Falcaria vulgaris) Extract and Studying its Effect on Second-degree Burn Injury Healing Process Compared to Conventional Sterile Gauze Dressing: An Experimental-Clinical Trial Study

Determining and comparing the trend of changes in the approximate area of the wound and the formation of scars around it in patients with second degree burn wounds between the two groups of nanofibers (placebo) and nanofibers containing the extract of Pagaze plant from the first day to the fifth week

A placebo controlled, triple blind, parallel group, randomized, phase 2-3 clinical trial on 54 patients. The rand function of Excel software will be used for randomization

Three groups of patients referring to Imam Khomeini Hospital in Kermanshah will be randomly selected and will be visited by the attending physician. After washing the wound by the nurse and applying the physician's orders on the wound, a group of nanofibers containing plant extract will be placed on the wound, and a placebo will be placed on the wound of another group, and the third group will be without intervention, then the wounds will be covered with sterile gauze and the dressings will be changed daily in the same way. Patients, clinical staff, statistical consultant and outcome evaluator were blinded

The inclusion criteria: patients with second degree burns who refer to Imam Khomeini Hospital in Kermanshah and are between 15 and 90 years old. Exclusion criteria: those patients who are pregnant or breastfeeding or are being treated with cytotoxic drugs or radiotherapy or have a survival chance of less than three months.

The control group will receive only the conventional treatment (sterile gauze dressing along with the drugs prescribed by the attending physician) In addition to conventional treatment, the other two groups will be dressed with nanofibers containing Pagaze extract or nanofibers without Pagaze extract (placebo)

Approximate wound area; scar formation

The samples will be selected by the random block method with blocks of 4 and using the rand function of the Excel software, a random sequence by a person not involved in the research (therapist). Registration of people is done by the clinic reception. Blocking and allocation sequence for concealment will be done by a person not involved in the research (therapist). The ratio of allocation of samples will be 1:1. A placebo with the same appearance as F.vulgaris extract is used to hide the randomization.

The dressings are prepared by the nanofiber manufacturer researcher in the same and numbered packaging for both groups A and B. The manufacturer's investigators will be unaware of which package will be used for which patient. It will be explained to the patients that you will receive the usual treatments, in addition, it is possible that the extract of the F.vulgaris extract will be used to heal your wound, and the clinical staff will not know exactly for whom this plant extract was used. The clinical staff and the analyst are unaware of which dressing is placebo and which dressing contains drug. The outcome evaluator is the researcher who made the dressing.

Age, gender, underlying disease as well as creation or non-creation of scars and the approximate area of the wound before and after the study can be shared

The start of the data access period is six months after the publication of the study results

All people working in universities and research centers will be allowed to send requests to receive data

Data sharing will be possible after receiving an official request from the relevant scientific center and only by clearly stating the reasons for the need to access the information and its use. Obviously, any use of the data outside of the application mentioned by the requester is not allowed

Dr. Reza Tahvilian: Faculty of Pharmacy, University of Medical Sciences, Bagh Abrisham, Kermanshah, Iran rtahvilian@kums.ac.ir Dr. Hossein Amiri: Mahdie Clinic, Moayed St., Kermanshah, Iran hossein.amirii@yahoo.com

After sending the request to the relevant researcher and confirming the receipt of the request by him, the requested information will be sent within 15 days