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Investigating the safety and effectiveness of smart biodegradable nanofiber dressing in the treatment of deep 2nd degree burn wounds (first and second phase of clinical trial)

Protocol summary

Study aim
Investigating the safety and effectiveness of smart biodegradable nanofiber dressing in the treatment of deep 2nd degree burn wounds (first and second phase of clinical trial)
Design
Randomized clinical trial phase 2, with a control group, with blinding, will be conducted on 16 patients and 32 volunteer wound sites.
Settings and conduct
The study will be performed in Velayat Hospital in Rasht and Mousavi hospital in Zanjan. 16 Men or women with second-degree Burning areas between 20-50% will be selected and enrolled in the study after signing a consent form. Wounds are first washed with normal saline, Then, according to groups type (intervention or control) a polymer dressing containing lactic acid and s-caprolactone or Suprathel wound dressing is placed on the wound sites and bandaged with sterile gauze. Before intervention and at the end of 1, 3 and, 7,14 and 28 days changes in burning parameters will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range from 18 to 65 years, acute burn in less than 24 hours, burn level of 20 to 50%, filling in the informed consent form, at least 2 recorded records of the variables of hospitalization in patients. exclusion criteria: pregnant women, underlying diseases.
Intervention groups
In the control group, a part of the patient's burn wound will be randomly selected and will receive the suprathel dressing, and in the intervention group, a part of the patient's burn wound will be randomly selected and will receive a polymer dressing containing lactic acid and s-caprolactone.
Main outcome variables
Local outcomes, systemic outcomes, duration of hospitalization, wound healing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231122060138N1
Registration date: 2023-12-03, 1402/09/12
Registration timing: prospective

Last update: 2023-12-03, 1402/09/12
Update count: 0
Registration date
2023-12-03, 1402/09/12
Registrant information
Name
Ahmadreza Mobayen
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6141
Email address
mobaien1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-11, 1402/09/20
Expected recruitment end date
2024-12-10, 1403/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the safety and effectiveness of smart biodegradable nanofiber dressing in the treatment of deep 2nd degree burn wounds (first and second phase of clinical trial)
Public title
Investigating effectiveness of smart biodegradable nanofiber dressing in the treatment of 2nd degree burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patient between 18 and 65 years old Refer to the treatment center in less than 24 hours Burn percentage ranges from 20-50% Fill out the informed consent form There should be at least 2 recorded records of the investigated variables. Patients should stay in the hospital for at least three days
Exclusion criteria:
Having severe hypertension BP≥160/90 mmHg High cardiac troponin pregnant women Immune system defect Anticoagulation problems, bleeding disorders, or heart disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 16
More than 1 sample in each individual
Number of samples in each individual: 2
In this research, according to the implementation method, a part of the burn wound of selected patients receives the original Supratel dressing and is considered as the control group, and another part of the patient's wound is randomly selected as the intervention group . They will receive lactic acid and s-caprolactone wound dressing.
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, in order to assign patients to the intervention and control groups, the restricted randomization approach will be used in parallel with the Random Allocation Rule method. In the random assignment process, the person who creates the random sequence is the analyst in this study. Also, the person who registers the participants based on the entry and exit criteria in the study will be one of the clinic nurses, and the person who allocates the participants in the intervention and control groups will be the project manager.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the researcher and the patient, dressings that are similar in color and shape are used in the control and intervention areas. The analyzer is blinded based on the coding of the dressings.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Zanjan University of Medical Sciences
Street address
The ethics committee of Zanjan University of Medical Sciences, first floor, Northside of Azadi Boulevard, Zanjan.
City
Zanjan
Province
Zanjan
Postal code
4525613113
Approval date
2023-10-31, 1402/08/09
Ethics committee reference number
IR.ZUMS.REC.1402.192

Health conditions studied

1

Description of health condition studied
Second degree burn
ICD-10 code
T20
ICD-10 code description
Burn and corrosion of head, face, and neck

Primary outcomes

1

Description
Local outcomes
Timepoint
At the beginning of the study (before the intervention) and 1, 3, 7, 14 and 28 days after applying the wound dressing
Method of measurement
Clinical observations and filling the checklist in 6 time points

2

Description
systemic outcomes
Timepoint
At the beginning of the study (before the intervention) and 1, 3, 7, 14 and 28 days after applying the wound dressing
Method of measurement
Clinical observations and filling the checklist in 6 time points

Secondary outcomes

1

Description
Wound healing rate
Timepoint
At the beginning of the study (before the intervention) and 1, 3, 7,14, and 28 days after applying the wound dressing
Method of measurement
Based on examination done by evaluators

Intervention groups

1

Description
Intervention group: Randomly, the site of the intervention group will be selected and will receive polymer dressing containing lactic acid and s-caprolactone.
Category
Treatment - Other

2

Description
Control group: A part of the burn wound of the patients is randomly selected and receives the original Suprathel dressing
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان ولایت
Full name of responsible person
دکتر محمدرضا مبین
Street address
3 floor, Burn and Regenerative Medicine Research Center, Velayat hospital, Namjo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
maziar.mobayen@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nedri
Street address
chancellor for Research and Technology of Zanjan University of Medical Sciences, first floor, Northside of Azadi Boulevard, Zanjan.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
nadri_s@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Ahmadreza Mobayen
Position
Tropical and Infectious Diseases Specialist
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Department of Infectious Diseases, valiasr Hospital, Sheikh Fazlolah ave, Zanjan-Iran
City
Zanjan
Province
Zanjan
Postal code
-
Phone
-
Email
amobaien@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ahmadreza Mobayen
Position
Tropical and Infectious Diseases Specialist
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Department of Infectious Diseases, Valiasr Hospital, Sheikh Fazlolah ave, Zanjan-Iran
City
Zanjan
Province
Zanjan
Postal code
-
Phone
-
Email
amobaien@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ahmadreza Mobayen
Position
Tropical and Infectious Diseases Specialist
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Department of Infectious Diseases, Valiasr Hospital, Sheikh Fazlolah ave, Zanjan-Iran
City
Zanjan
Province
Guilan
Postal code
-
Phone
-
Email
amobaien@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
-
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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