Protocol summary

Study aim
Comparison of the use of nanocellulose dressing with the standard method of burn treatment in the recovery of patients with 2nd degree burns.
Design
Controlled clinical trial with parallel groups, without blinding, randomized, phase 3 on 24 patients. Lottery of sealed envelopes will be used for randomization.
Settings and conduct
This trial will be conducted as a single center in the Shahid Madani accident center of Karaj. The number of 24 patients who meet the necessary conditions to participate in the study will be included in the study and randomly and by lottery will be placed in one of the groups of standard treatment or treatment with nanocellulose dressing. Duration of hospitalization, wound healing time, wound infection, hypertrophic scar and patient satisfaction with the treatment will be measured. The level of pain and itching of the patient on the first to third day will also be checked using VAS and finally all these items will be compared between the study groups.
Participants/Inclusion and exclusion criteria
Having second-degree burns in the limbs or trunk (with TBSA below 10%), being 18 and 75 years old, as well as not having chronic heart, vascular, liver and kidney diseases، not being pregnant, absence of infection in the burn wound and not being under treatment with systemic cortisone
Intervention groups
The nanocellulose coating is placed on the wound and covered with a sterile gauze. In this group, the dressing will be changed every three days without removing the nanocellulose dressing.
Main outcome variables
Duration of hospitalization, wound healing time, wound infection, hypertrophic scar and patient satisfaction, the level of pain and itching of the patient on the first to third day

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160117026069N6
Registration date: 2023-01-26, 1401/11/06
Registration timing: prospective

Last update: 2023-01-26, 1401/11/06
Update count: 0
Registration date
2023-01-26, 1401/11/06
Registrant information
Name
Fereshteh Ansari
Name of organization / entity
Razi Vaccine and Serum Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 26 3405 0400
Email address
ansarif@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of bacterial nanocellulose wound dressings and standard treatment in the healing of second degree burn wounds: a randomized controlled clinical trial
Public title
Bacterial nanocellulose wound dressings for the healing of second degree burn wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having second degree burns on the limbs or trunk (with TBSA below 10%)
Exclusion criteria:
Pregnancy Chronic heart, kidney and liver diseases Wound infection Systematic cortisone use
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelopes are considered as the number of patients, whose content determines which group each person belongs to. One of these envelopes is selected for each patient by lottery, and then this envelope is opened and the allocation of the patient will be determined after opening the envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Saffarian Alley, Golshahr Blvd, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2023-01-08, 1401/10/18
Ethics committee reference number
IR.ABZUMS.REC.1401.283

Health conditions studied

1

Description of health condition studied
Second degree burn ulcer
ICD-10 code
M61.3
ICD-10 code description
Calcification and ossification of muscles associated with burns

Primary outcomes

1

Description
Duration of hospitalization
Timepoint
When the patient discharged from the hospital
Method of measurement
Information recorded in the patient file

2

Description
Duration of recovery
Timepoint
Daily until hospitalization and weekly visits thereafter
Method of measurement
Observation of the physician

Secondary outcomes

1

Description
Wound infection
Timepoint
Daily during hospitalization and weekly visits thereafter
Method of measurement
Observation of the physician

2

Description
Hypertrophic scar
Timepoint
The last visit
Method of measurement
Observation of the physician

3

Description
Patient satisfaction
Timepoint
The last visit
Method of measurement
Questioning the patient in the form of yes or no

4

Description
Pain
Timepoint
First day, second day, third day
Method of measurement
Asking the patient based on the VAS scale

5

Description
Itching
Timepoint
First day, second day, third day
Method of measurement
Asking the patient based on the VAS scale

Intervention groups

1

Description
Intervention group: After preliminary and necessary measures such as washing and disinfecting the wound, nanocellulose coating is placed on the wound and covered with a sterile gauze. In this group, the dressing will be changed every three days without removing the nanocellulose dressing.
Category
Treatment - Other

2

Description
Control group: After preliminary and necessary measures such as washing and disinfecting the wound, the dressing is done using usual ointments (usual treatment) and the whole dressing is changed once every three to five days.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani medical eduction and treatment center
Full name of responsible person
Leila Hajimaghsoudi
Street address
Shahid Madani medical eduction and treatment center, Shahid Madani Sq., Shahid Madani Blvd., Talegani Ave.
City
Karaj
Province
Alborz
Postal code
3143744693
Phone
+98 26 3442 7001
Email
L.hajimaghsoudi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Street address
Vice-Chancellor for Research and Technology, Gulshahr, Safarian Alley
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
raziehlotfi@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Hadi Pourjafar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Food safety and Health
Street address
Vice-Chancellor for Research and Technology, Gulshahr, Safarian Alley
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
pourjafarhadi59@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Leila Hajimaghsoudi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Madani medical eduction and treatment center, Shahid Madani Sq., Shahid Madani Blvd., Talegani Ave.
City
Karaj
Province
Alborz
Postal code
3143744693
Phone
+98 26 3442 7001
Email
L.hajimaghsoudi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Razi Vaccine and Serum Research Institute
Full name of responsible person
Fereshteh Ansari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Shahid Beheshti Ave., Hesarak
City
Karaj
Province
Alborz
Postal code
3197619751
Phone
+98 26 3405 0400
Fax
+98 26 3455 2194
Email
fereshtehansari66@gmail.com

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
Not applicable
Title and more details about the data/document
All of the participants' individual data
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
All researchers working in academic and scientific institutions and people working in the industry
Under which criteria data/document could be used
If a request with this theme is received, a decision will be made with the opinion of the research team.
From where data/document is obtainable
To the project manager, Dr. Hadi Pourjafar
What processes are involved for a request to access data/document
After submitting the request to the project manager, this request will be reviewed by a committee with the presence of all the people involved in the project, and then if the committee gives a positive answer, the data will be provided to the applicant.
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