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IRCT20260630070020N1 IRCT 2026-07-09 Yasouj University of Medical Sciences Effect of Safflower Oil on Postoperative Wounds Following Pilonidal Cyst Surgery 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 2026-08-06 anticipated 60 Complete https://irct.ir/trial/91371 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2-3 Pilonidal cyst. Intervention 1: Intervention group: In addition to standard treatment, patients will receive topical safflower seed oil (Carthamus tinctorius). After washing the wound daily, approximately a fingertip of the oil is placed on a gauze pad and applied to the wound bed, followed by a dressing. The dressing will be changed every 24 hours for the first week and every 48 hours from the second week onwards for a period of 4 weeks. Intervention 2: Control group: Patients will receive standard wound care, which includes daily irrigation of the wound with normal saline and dressing with plain sterile gauze, without the use of safflower seed oil or other topical products. The dressing will be changed every 24 hours for the first week and every 48 hours from the second week onwards for a period of 4 weeks. Yes - There is a plan to make this available What will be shared: After the completion of the study, all study data will be shared after being de-identified When: One month after the completion of the intervention, the data of the main variables of the study will be shared To whom: After The Publication Of The Article, all individuals will have access to its content Conditions: Individuals associated with the medical and therapeutic fields may utilize the data from this study to conduct new research Where to obtain: Via official email to the corresponding author at: r_hosseinpour@yahoo.com. How to obtain: 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. Comments:
public Ali Keshvari Khanimeni
Shahid Zarei Educational Campus, Beach Park Towards Imam Sajjad (AS) Hospital, Yasuj
Yasuj Iran (Islamic Republic of) 7591875111 +98 74 3323 5153 Alikeshvari0060@gmail.com Yasouj University of Medical Sciences scientific Reza Hossein-pour
Shahid Zarei Educational Campus, Beach Park Towards Imam Sajjad (AS) Hospital, Yasuj
Yasuj Iran (Islamic Republic of) 7591875111 +98 74 3332 5153 r_hosseinpour@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Definitive 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 18 years 60 years Both Having diabetes History of clotting disorders or deep vein thrombosis L05 Pilonidal cyst and sinus Treatment - Other Treatment - Other Intervention group: In addition to standard treatment, patients will receive topical safflower seed oil (Carthamus tinctorius). After washing the wound daily, approximately a fingertip of the oil is placed on a gauze pad and applied to the wound bed, followed by a dressing. The dressing will be changed every 24 hours for the first week and every 48 hours from the second week onwards for a period of 4 weeks. Control group: Patients will receive standard wound care, which includes daily irrigation of the wound with normal saline and dressing with plain sterile gauze, without the use of safflower seed oil or other topical products. The dressing will be changed every 24 hours for the first week and every 48 hours from the second week onwards for a period of 4 weeks. Pain intensity. Timepoint: Before and after the intervention. Method of measurement: Using a visual analog scale (VAS). Wound healing time. Timepoint: After the intervention. Method of measurement: Using the PUSH scale. Yasouj University of Medical Sciences Approved 2026-05-20 Ethics committee of Yasuj University of Medical Sciences Daneshgah St., Motahari Blvd., Jahad Town Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)