Protocol summary

Summary
The purpose of the present study was to compare the healing effects of silver nano spray and silver sulfadiazine on second-degree burns. A sample of 42 participants were selected for the study from among the patients arriving at the hospital using the following inclusion criteria: 1) they suffered from burns caused by liquids ( but not by acids) or a heating source, 2) they had burns on two separate parts of the body with similar depth, 3) they were between 18 an 60 years of age, 4) they showed no indication of diabetes, cardiovascular diseases, or skin allergy, nor did they suffered defects or problems in their immune system. The participants were excluded from the study if they showed their discontent for any possible reason. After the patients with a second-degree burn arrived at the hospital, a specialist examined their burns and gave them a score using Bates and Johnson instrument (test). After it was cleansed by sterile saline, the burn was divided into two equal halves. The first half was covered with a two-millimeters thick silver sulfadiazine dressing (pad) while the other was coated with silver by a silver nano spray (two puffs on a 2cm*2cm burn injury). Next, the two halves were covered by Vaseline gauze dressings. The burns dressings were changed every day by the present researcher. Moreover, the researcher took photos of the burns every day. On the first, third, seventh, fourteenth, and twenty first days after the patients arrival at the hospitals, however, their burns were ranked and a score was given to them using Bates and Johnson instrument. The same procedure and materials were used every day to change the burns dressings. The patients were insisted to come to the hospital after leaving to have the dressings of their burns changed. In case, any allergies was diagnosed, a specialist was called in to treat it. Finally, on the twenty first day, the burn injuries were examined by the specialist and a final score was given to each burn. A blind study as a physician based on photos taken from the ulcer using the tool Bates - Jensen to score and the type of wound healing does not know.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010331752N1
Registration date: 2017-03-01, 1395/12/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-01, 1395/12/11
Registrant information
Name
Azita Dolatabadi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4423 8850
Email address
dovlatabadia92@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2016-12-30, 1395/10/10
Expected recruitment end date
2017-07-01, 1396/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of silver nano spray and silver sulfadiazine 1% on wound healing in burns.
Public title
The effect of burn cream silver sulfadiazine and silvernano spray burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: burns from heat source or liquid;Visit of the burn until less than 24 hours previously; Patients aged between 18 -60 years;The absence of diabetes, cardiovascular disease, skin sensitivity; The absence of any type of immunodeficiency disease. Exclusion criteria:Not wanting to work for any reason; transfer or death of the patient;drug allergy symptoms, according to the doctor.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
25/5000 Sabzevar University of Medical Sciences
Street address
22/5000 Sabzevar road Tohid
City
sabzevar
Postal code
Approval date
2016-02-12, 1394/11/23
Ethics committee reference number
با کد اخلاق (IR.MEDSAB.REC.1394.93)

Health conditions studied

1

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

Primary outcomes

1

Description
Wound size
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

2

Description
Deep wounds
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

3

Description
Wound edge
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

4

Description
Loss
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

5

Description
Necrotic tissue
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

6

Description
The amount of necrotic tissue
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

7

Description
Exudate
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

8

Description
12/5000 The amount of exudate
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

9

Description
The color of the skin around the wound
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

10

Description
18/5000 Tissue edema around the wound
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

11

Description
endorasion
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

12

Description
Granulation
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

13

Description
Epithelialization
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

14

Description
Total score of wounds
Timepoint
1-3-7-14-21
Method of measurement
Tools Bates - Jensen

Secondary outcomes

empty

Intervention groups

1

Description
wound has been divided into two equal parts and one part silver sulfadiazine to a thickness of 2 mm and the other with silvernano spray at 2 puff covered and then dresse
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital vasei sabzevar
Full name of responsible person
Researcher
Street address
Sabzevar University of Medical Sciences
City
sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dolatabadi Azita
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Vaheb Mojtaba
Position
Plastic surgery
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences
City
Sabzenar
Postal code
Phone
+98 51 4401 4000
Fax
Email
drvaheb@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dolatabadi Azita
Position
Nursing Expert
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 51 4464 0115
Fax
Email
azitadolatabadi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dolatabadi Azita
Position
Nurse
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 51 4464 0115
Fax
Email
azitadolatabadi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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