Preparation and fabrication of nanofibrous wound dressings based on polycaprolactone, gelatin, and methacrylated copolymer and clinical evaluation of nanofibrous wound dressings on superficial second-degree burn wounds
Design
The clinical trial has three intervention groups and one control group, double-blind, randomized, phase 1 on 45 second-degree burn patients.
Settings and conduct
Initially, three groups of nanofibrous wound dressings, including polycaprolactone/gelatin wound dressing, polycaprolactone/methacrylated copolymer wound dressing, and methacrylated copolymer wound dressing, were prepared using the electrospinning method. Patients who met the inclusion criteria were enrolled in the study. Sterility, washing, and disinfection of the burn site were performed uniformly for all patients across the entire wound surface according to hospital protocols. The wound area was then divided into two parts, and the type of dressing was randomly assigned to each site with the patient’s awareness. A nanofibrous wound dressing was applied to area A, while a Mepilex foam dressing (control sample) was applied to area B. Finally, the evaluation was carried out on superficial second-degree burn wounds, and the variables were studied.
Patient recruitment and the study were conducted in two centers: Shahid Motahari Hospital in Tehran and Kawsar Hospital in Sanandaj.
Re-epithelialization rate; wound healing time; wound healing quality; dressing changes during the treatment period; comfort; pain; dressing adhesion; erythema; edema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250408065259N1
Registration date:2025-12-21, 1404/09/30
Registration timing:registered_while_recruiting
Last update:2025-12-21, 1404/09/30
Update count:0
Registration date
2025-12-21, 1404/09/30
Registrant information
Name
Mohamad Pezeshki-Modaress
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 7272
Email address
pezeshkimodaress.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-12, 1403/05/22
Expected recruitment end date
2026-02-21, 1404/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of electrospun nanofibrous wound dressing on superficial second-degree burn wounds (clinical trial phase I)
Public title
Evaluation of electrospun wound dressing on burn wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
2
Each participant receives a coded study sample and a conventional control sample simultaneously.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
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
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of Iran University of Medical Sciences
Street address
Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences, Central Headquarters Building, Vice President for Research and Technology
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-01-17, 1402/10/27
Ethics committee reference number
IR.IUMS.REC.1402.938
Health conditions studied
1
Description of health condition studied
superficial second-degree burn wounds
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
Re-epithelialization
Timepoint
Day 0, 4, 9, and 14
Method of measurement
Photography using Image J software
2
Description
Wound healing quality
Timepoint
Day 0, 4, 9, and 14
Method of measurement
Surgeon evaluation through scoring poor, moderate, good, and excellent
3
Description
Wound dressing change
Timepoint
During the treatment period
Method of measurement
Surgeon's evaluation
4
Description
Patient comfort level
Timepoint
End of study
Method of measurement
By the patient through scoring of dissatisfaction, moderate, good and excellent
5
Description
Pain
Timepoint
Day 0, 4, 9, and 14
Method of measurement
Visual Analogue Scale
6
Description
Wound dressing adhesion
Timepoint
End of study
Method of measurement
Surgeon's evaluation through scoring of dissatisfaction, moderate, good and excellent
7
Description
Erythema
Timepoint
End of study
Method of measurement
Surgeon's evaluation through scoring of Very low, low, moderate and severe
8
Description
Edema
Timepoint
End of study
Method of measurement
Surgeon's evaluation through scoring of without edema, low, moderate and severe
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Devices
3
Description
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.
Category
Treatment - Devices
4
Description
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.
Central Headquarters, 5th floor, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8862 2703
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohamad Pezeshki Modaress
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biopolymers
Street address
Hazrate Fatemeh Hospital, Asadabadi St., Yousef Abad
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
pezeshkimodaress.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tayyeb Ghadimi
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic & Reconstructive Surgery
Street address
Burn Research Center, Shahid Motahari Hospital, Rashid Yasemi St, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996714353
Phone
+98 21 8888 4275
Email
tayyeb.ghadimi5@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohamad Pezeshki Modaress
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biopolymers
Street address
Hazrate Fatemeh Hospital, Asadabadi St., Yousef Abad
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
pezeshkimodaress.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Questionnaires, study protocol; statistical analysis; consent forms, clinical study report; codes used in analysis; data classification system
When the data will become available and for how long
The access period begins 12 months after the results are published.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
It is possible to use data/documents for research purposes.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
One month after receiving the email and confirming the application details