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Safety and efficacy assessment of Polyurethane film for healing superficial second-degree (partial thickness) burns: Phase 1 clinical trial

Protocol summary

Study aim
Safety and efficacy assessment of Polyurethane (PU) film for healing superficial second-degree burns
Design
The study is phase 1 clinical trial. In this study, 10 patients with superficial Second-Degree burn between 10 to 25 percent total burn surface area was selected. The sampling is voluntary. The study is not blinded.
Settings and conduct
The site of the study is Imam Musa Kazim hospital of Isfahan. A part of superficial second degree burn area (excluding sensitive areas of the body) is covered with a piece of 8×8 cm2 transparent PU film. The patient condition and burned area are checked every day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: (1) Female or male between 18 and 60 years old; (2) Second-degree burns; (3) Total burn surface area between 10-25%. Exclusion criteria: (1) Presence of underlying medical conditions; (2) Subjects with Systemic infections receiving antibiotic treatment; (3) Need to consumption immunosuppressive drugs‎, Corticosteroids or chemotherapy; (4) Pregnancy, breastfeeding, and presence of trauma.
Intervention groups
First, the blisters and dead tissue of the wound are removed and the burned area is washed. Then a piece of 8×8 cm2 transparent PU film is placed on a part of the superficial 2nd degree burn (except for the sensitive areas of the body) and fixed with sterile gas or bandage. The patient is hospitalized or referred to the hospital during treatment and the patient's condition and burned area are checked.
Main outcome variables
Healing time (day); Pain, itching and burning (0 to 10); The color of the wound from the beginning to the end of the treatment (Pink, red, brown or gray); Amount of exudate\inflammation (0 to 3).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210414050966N1
Registration date: 2021-09-09, 1400/06/18
Registration timing: prospective

Last update: 2021-09-09, 1400/06/18
Update count: 0
Registration date
2021-09-09, 1400/06/18
Registrant information
Name
Sayed Mohammad Razavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5579
Email address
razavi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy assessment of Polyurethane film for healing superficial second-degree (partial thickness) burns: Phase 1 clinical trial
Public title
Safety and efficacy assessment of Polyurethane film for healing superficial second-degree burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female or male between 18 and 60 years old Second-degree burn that are expected to heal in two to three weeks. Burns have been caused by contact with a heat source or hot liquids. Total body surface area in burns (TBSA) between10% - 25% based on Lund and Browder chart Burned within the first 72 hours. No signs of infection in the wound
Exclusion criteria:
Presence of Underlying Medical Conditions such as dermatosis, allergy, cancer, renal failure, anemia, diabetes, cardiovascular disease, malignancy, immunodeficiency Injury to burn wounds during care Subjects with systemic infections receiving antibiotic treatment Need to consumption immunosuppressive drugs‎, Corticosteroids, chemotherapy, and radiation therapy during the experiment Subjects declined participation and no referral to the hospital for continuing the treatment Pregnancy, breastfeeding, and presence of trauma
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 10
More than 1 sample in each individual
Number of samples in each individual: 1
In each sample, a part of the superficial second degree burn is covered with the Polyurethane film .
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.827

Health conditions studied

1

Description of health condition studied
Burn of superficial second-degree
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified

Primary outcomes

1

Description
Inflammation
Timepoint
Daily
Method of measurement
Based on the physician's observation

2

Description
Itching and burning
Timepoint
Daily
Method of measurement
According to the VAS criteria

Secondary outcomes

1

Description
Healing time
Timepoint
Daily
Method of measurement
Based on the physician's observation

2

Description
Amount of pain
Timepoint
Daily
Method of measurement
According to the VAS criteria

3

Description
color of burn wound
Timepoint
Daily
Method of measurement
Based on the physician's observation

4

Description
Amount of exudate
Timepoint
Daily
Method of measurement
Based on the physician's observation

Intervention groups

1

Description
For patients with second-degree burn, at first blisters and dead tissue are removed and the wound area is washed with a disinfectant solution (such as hexisept (chlorhexidine), actiniscept, or 0.5% sodium hypochlorite (500 ppm)). Then a piece of PU film with dimensions of 8* 8 cm2 is placed on a part of the superficial 2nd degree burn (except for the sensitive areas of the body) and fixed with sterile gas or bandage. The dressing remains on the burn area for the entire duration of the treatment with the approval of the doctor. During 14 to 21 days of treatment, the patient was hospitalized or referred to the hospital again and the general condition of the patient and the place covered with PU film are checked.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Musa Kazim hospital of Isfahan
Full name of responsible person
Fereydoon Abedini
Street address
Kaveh Blvd
City
Isfahan
Province
Isfehan
Postal code
81388 94948
Phone
+98 31 3345 7670
Email
Fereydoonabedini@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Avicenna Center of Excellence
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
School of Advanced Technologies in Medicine, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3851
Email
amt@mui.ac.ir
Web page address
https://amt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Avicenna Center of Excellence
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
Esfahan University of Medical Sciences
Full name of responsible person
Sayed Mohammad Razavi
Position
Professor and faculty member of the Department of Oral and Maxillofacial Pathology, school of Dentis
Latest degree
Specialist
Other areas of specialty/work
Pathology
Street address
School of Dentistry, Isfahan University of Medical Science, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5579
Email
razavi@dnt.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fereydoon Abedini
Position
General Surgeon and member of Department of surgery and burn center team of Imam Musa Kazim Hospital
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Musa Kazim Hospital, Kaveh Blvd, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8138894948
Phone
+98 31 3345 7670
Email
Fereydoonabedini@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Technology
Full name of responsible person
Saied Nouri-Khorasani
Position
Professor of Polymer Group, Dept. of Chemical Engineering
Latest degree
Ph.D.
Other areas of specialty/work
Polymer Engineering
Street address
Polymer Group, Chemical Engineering Dept., Isfahan University of Technology, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8415683111
Phone
+98 31 3391 5612
Email
saied@iut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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