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IRCT20250408065259N1 IRCT 2025-12-21 Iran University of Medical Sciences Evaluation of electrospun wound dressing on burn wound Evaluation of electrospun nanofibrous wound dressing on superficial second-degree burn wounds (clinical trial phase I) 2024-08-12 anticipated 45 Complete https://irct.ir/trial/82921 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants and the surgeon The samples are coded by the project executor in similar packaging and provided to the surgeon. Therefore, neither the patient nor the doctor is aware of the type of wound dressings, and the reports are completed only with the assigned codes. 1 superficial second-degree burn wounds. Intervention 1: This intervention includes patients with superficial second-degree burn wounds who receive a polycaprolactone/gelatin electrospun nanofibrous dressing with an area of ​​100 cm2 (10 cm x 10 cm). An explanation of the objectives of the study and the type of dressing used is given to the patient and a written consent is obtained from him/her. The number of patients is 10 to 15. First, the sterility conditions, washing and disinfection of the burn site are performed similarly in all patients according to hospital protocols across the entire wound surface. Then the wound area is divided into two parts (for dressing and control), and the type of dressing is assigned to the wound site randomly. After implementing the above protocol, the aforementioned nanofibrous dressing is placed on the wound and studied over a 14-day period on days 0, 4, 9 and 14. It should be noted that the dressing was fabricated by the research team and is simply a nanofibrous dressing without a drug component. Intervention 2: This intervention includes patients with superficial second-degree burn wounds who receive a polycaprolactone/methacrylate copolymer electrospun nanofibrous dressing with an area of ​​100 cm2 (10 cm x 10 cm). An explanation of the objectives of the study and the type of dressing used is given to the patient and a written consent is obtained from him/her. The number of patients is 10 to 15. First, the sterility conditions, washing and disinfection of the burn site are performed similarly in all patients according to hospital protocols across the entire wound surface. Then the wound area is divided into two parts (for dressing and control), and the type of dressing is assigned to the wound site randomly. After implementing the above protocol, the aforementioned nanofibrous dressing is placed on the wound and studied over a 14-day period on days 0, 4, 9 and 14. It should be noted that the dressing was fabricated by the research team and is simply a nanofibrous dressing without a drug component. Intervention 3: This intervention includes patients with superficial second-degree burn wounds who receive a methacrylate copolymer electrospun nanofibrous dressing with an area of ​​100 cm2 (10 cm x 10 cm). An explanation of the objectives of the study and the type of dressing used is given to the patient and a written consent is obtained from him/her. The number of patients is 10 to 15. First, the sterility conditions, washing and disinfection of the burn site are performed similarly in all patients according to hospital protocols across the entire wound surface. Then the wound area is divided into two parts (for dressing and control), and the type of dressing is assigned to the wound site randomly. After implementing the above protocol, the aforementioned nanofibrous dressing is placed on the wound and studied over a 14-day period on days 0, 4, 9 and 14. It should be noted that the dressing was fabricated by the research team and is simply a nanofibrous dressing without a drug component. Intervention 4: The control group also includes patients with superficial second-degree burns who receive a commercial polyurethane-based foam dressing, Mepilex , from Monlike, Sweden, as a wound covering bed without a drug component, with an area of ​​100 square centimeters (10 cm x 10 cm). The objectives of the study and the type of dressings used are explained to the patient and a written consent is obtained from him/her. The number of patients is 10 to 15. First, the sterility conditions, washing and disinfection of the burn site are performed similarly in all patients according to hospital protocols over the entire wound surface. Then, the wound area is divided into two parts (for dressing and control), and the type of dressing is assigned to the wound site randomly. After implementing the above protocol, the commercial dressing is placed on the wound and studied over a period of 14 days on days 0, 4, 9 and 14. Yes - There is a plan to make this available What will be shared: Questionnaires, study protocol; statistical analysis; consent forms, clinical study report; codes used in analysis; data classification system When: The access period begins 12 months after the results are published. To whom: Academic researchers Conditions: It is possible to use data/documents for research purposes. Where to obtain: Burn Research Center, Iran University of Medical Sciences Address: Burn Research Center, Shahid Motahari Hospital, Rashid Yasemi Street, Valiasr Street postal Code: 1996714353 Contact Number: 02188884275 email: burncenter.iran@gmail.com How to obtain: One month after receiving the email and confirming the application details Comments:
public Mohamad Pezeshki Modaress
Hazrate Fatemeh Hospital, Asadabadi St., Yousef Abad
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 pezeshkimodaress.m@iums.ac.ir Iran University of Medical Sciences scientific Tayyeb Ghadimi
Burn Research Center, Shahid Motahari Hospital, Rashid Yasemi St, Valiasr St.
Tehran Iran (Islamic Republic of) 1996714353 +98 21 8888 4275 tayyeb.ghadimi5@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18–70 years Both sexes Superficial second-degree burn wounds No prior burns at the current site No acute psychiatric disorders No comorbidities No immunosuppressive therapy No massive unstable trauma Completion of informed consent form 18 years 60 years Both First and third degree burn wounds burns on joints, face, perineum Pregnancy or breastfeeding Patients with diabetic and infected wounds Presence of a chronic skin disease T30.2 Burn of second degree, body region unspecified Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices This intervention includes patients with superficial second-degree burn wounds who receive a polycaprolactone/gelatin electrospun nanofibrous dressing with an area of ​​100 cm2 (10 cm x 10 cm). An explanation of the objectives of the study and the type of dressing used is given to the patient and a written consent is obtained from him/her. The number of patients is 10 to 15. First, the sterility conditions, washing and disinfection of the burn site are performed similarly in all patients according to hospital protocols across the entire wound surface. Then the wound area is divided into two parts (for dressing and control), and the type of dressing is assigned to the wound site randomly. After implementing the above protocol, the aforementioned nanofibrous dressing is placed on the wound and studied over a 14-day period on days 0, 4, 9 and 14. It should be noted that the dressing was fabricated by the research team and is simply a nanofibrous dressing without a drug component. This intervention includes patients with superficial second-degree burn wounds who receive a polycaprolactone/methacrylate copolymer electrospun nanofibrous dressing with an area of ​​100 cm2 (10 cm x 10 cm). An explanation of the objectives of the study and the type of dressing used is given to the patient and a written consent is obtained from him/her. The number of patients is 10 to 15. First, the sterility conditions, washing and disinfection of the burn site are performed similarly in all patients according to hospital protocols across the entire wound surface. Then the wound area is divided into two parts (for dressing and control), and the type of dressing is assigned to the wound site randomly. After implementing the above protocol, the aforementioned nanofibrous dressing is placed on the wound and studied over a 14-day period on days 0, 4, 9 and 14. It should be noted that the dressing was fabricated by the research team and is simply a nanofibrous dressing without a drug component. This intervention includes patients with superficial second-degree burn wounds who receive a methacrylate copolymer electrospun nanofibrous dressing with an area of ​​100 cm2 (10 cm x 10 cm). An explanation of the objectives of the study and the type of dressing used is given to the patient and a written consent is obtained from him/her. The number of patients is 10 to 15. First, the sterility conditions, washing and disinfection of the burn site are performed similarly in all patients according to hospital protocols across the entire wound surface. Then the wound area is divided into two parts (for dressing and control), and the type of dressing is assigned to the wound site randomly. After implementing the above protocol, the aforementioned nanofibrous dressing is placed on the wound and studied over a 14-day period on days 0, 4, 9 and 14. It should be noted that the dressing was fabricated by the research team and is simply a nanofibrous dressing without a drug component. The control group also includes patients with superficial second-degree burns who receive a commercial polyurethane-based foam dressing, Mepilex , from Monlike, Sweden, as a wound covering bed without a drug component, with an area of ​​100 square centimeters (10 cm x 10 cm). The objectives of the study and the type of dressings used are explained to the patient and a written consent is obtained from him/her. The number of patients is 10 to 15. First, the sterility conditions, washing and disinfection of the burn site are performed similarly in all patients according to hospital protocols over the entire wound surface. Then, the wound area is divided into two parts (for dressing and control), and the type of dressing is assigned to the wound site randomly. After implementing the above protocol, the commercial dressing is placed on the wound and studied over a period of 14 days on days 0, 4, 9 and 14. Re-epithelialization. Timepoint: Day 0, 4, 9, and 14. Method of measurement: Photography using Image J software. Wound healing quality. Timepoint: Day 0, 4, 9, and 14. Method of measurement: Surgeon evaluation through scoring poor, moderate, good, and excellent. Wound dressing change. Timepoint: During the treatment period. Method of measurement: Surgeon's evaluation. Patient comfort level. Timepoint: End of study. Method of measurement: By the patient through scoring of dissatisfaction, moderate, good and excellent. Pain. Timepoint: Day 0, 4, 9, and 14. Method of measurement: Visual Analogue Scale. Wound dressing adhesion. Timepoint: End of study. Method of measurement: Surgeon's evaluation through scoring of dissatisfaction, moderate, good and excellent. Erythema. Timepoint: End of study. Method of measurement: Surgeon's evaluation through scoring of Very low, low, moderate and severe. Edema. Timepoint: End of study. Method of measurement: Surgeon's evaluation through scoring of without edema, low, moderate and severe. Iran University of Medical Sciences Approved 2024-01-17 Research Ethics committees of Iran University of Medical Sciences Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences, Central Headquarters Building, Vice President for Research and Technology Tehran Tehran Iran (Islamic Republic of)