The Effect of Topical Safflower (Carthamus tinctorius L.) Seed Oil on Open Wound Healing in Patients with Pilonidal Sinus Following Surgery: A Randomized Controlled Clinical TriaL

Determining the local effect of safflower seed oil (Carthamus tinctorius) on the healing process of open wounds in patients with pilonidal cysts after surgery

A controlled, parallel-group, single-blind, randomized, phase 2 clinical trial on 60 patients. The sealedenvelop website will be used for randomization.

This study will be conducted in Yasuj, Iran. Eligible participants will be randomly allocated to the intervention and control groups using block randomization. The intervention group will receive topical safflower seed oil, while the control group will receive standard wound care. Wound healing will be assessed weekly. Outcome assessor blinding will be implemented, with the assessor remaining unaware of participants' group allocation.

Major inclusion criteria: Definite diagnosis of pilonidal disease by a surgeon and open excision surgery Absence of clinical signs of active wound infection at the time of study entry Major exclusion criteria: Diabetes Vascular disorders

The intervention group will be given safflower oil, which will be applied daily to the area of ​​the wound, using a fingernail-sized amount, after washing the wound with ordinary gauze, and then applied to the wound and bandaged. The control group will receive standard treatment, including washing and dressing with ordinary gauze daily. The intervention period is 4 weeks.

Wound healing time; pain intensity

Participants in this study will be allocated to the intervention and control groups using **block randomization** with **individual randomization** as the unit of randomization. To ensure balanced group sizes and reduce the predictability of treatment allocation, **random blocks of variable sizes (2, 4, 6, and 8)** will be used. **Stratified randomization** will not be applied. The random allocation sequence will be generated using the **Sealed Envelope** website, and participants will be assigned to either the intervention group (A) or the control group (B) according to the generated sequence. To ensure **allocation concealment**, the randomization sequence will be maintained by an independent third party, and a unique study code will be assigned to each participant before enrollment, ensuring that the researcher remains unaware of the participant's treatment allocation until the time of assignment.

In this study, patient blinding will not be performed. Because the comparison will be made with the standard treatment, which only includes washing and dressing, and the use of ointment has no place in the standard treatment. However, the blinding of the evaluator will be performed. In this way, the patients will be fully aware in advance that they will not provide the evaluator with information about their treatment during periodic assessments, and the evaluator will not ask about the type of treatment of the patients during periodic assessments. At the beginning of the study, the third party will provide each patient with a unique code, then record the information related to the patient's allocation to one of the study groups along with the unique code, and at the end of the study, after data collection, the recorded information will be made available to the researcher for data analysis.

After the completion of the study, all study data will be shared after being de-identified

One month after the completion of the intervention, the data of the main variables of the study will be shared

After The Publication Of The Article, all individuals will have access to its content

Individuals associated with the medical and therapeutic fields may utilize the data from this study to conduct new research

Via official email to the corresponding author at: r_hosseinpour@yahoo.com.

The applicant must submit their formal request via the organization's email to the responsible author's email address. The accountable author will provide the information to the applicant within a maximum of 2 weeks after the applicant confirms the information.