A comparative study of the therapeutic effect of collagen superabsorbent powder containing silver nanoparticles 15 ppm and 1% silver sulfadiazine ointment on the healing of bedsore.
Determining the therapeutic effect of superabsorbent collagen powder containing 15ppm silver nano particles compared to 1% silver sulfadiazine ointment on bed wound healing.
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized, phase 3 on 68 patients
Settings and conduct
Wound healing clinics and nursing homes in Isfahan city
Measuring the surface of the wound using caliper software.
Washing the wound with 0.9% sterile saline.
A few puffs of Nivasha nano silver spray are applied on the surface of the wounds to sterilize the surface of the wounds. After that, 1% silver sulfadiazine or superabsorbent collagen powder containing silver nanoparticles is poured on the wounds, and a layer of vaseline gauze and sterile gauze are placed on the wounds, respectively. It is placed and bandaged by bandage.
The wound dressing is changed every 48 hours in the case of the intervention group and daily in the case of the comparison group until the wound is completely healed.
Participants/Inclusion and exclusion criteria
Patients aged 35-80 years with at least 30-day-old ulcers.
The wound should be defined as a cavitary bed wound, Wagner grade 3-4.
No local or systemic signs of infection,
With normal CRP and leukocyte levels
Intervention groups
34 patients in the intervention group will be dressed with collagen superabsorbent powder containing silver nanoparticles (with a concentration of 15 ppm) and 34 patients in the comparison group will be dressed with 1% silver sulfadiazine ointment (trade name Flamexin).
Main outcome variables
Frequency distribution of recovery rate , Average recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230621058552N2
Registration date:2023-07-13, 1402/04/22
Registration timing:prospective
Last update:2023-07-13, 1402/04/22
Update count:0
Registration date
2023-07-13, 1402/04/22
Registrant information
Name
maryam aghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 2206
Email address
maryam.aghaei2008@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2025-02-03, 1403/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the therapeutic effect of collagen superabsorbent powder containing silver nanoparticles 15 ppm and 1% silver sulfadiazine ointment on the healing of bedsore.
Patients aged 35-80 years with at least 30-day-old ulcers. The wound should be defined as a cavitary bed wound, Wagner grade 3-4. No local or systemic signs of infection, with normal CRP and leukocyte levels
Exclusion criteria:
Age
From 35 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
They are divided into two intervention and comparison groups through the table of random numbers. These tables have random numbers in both row and column directions, which usually reach 99 rows and columns, and the numbers of the rows and columns are in blocks of five digits next to each other and in a separated form to facilitate its use. Then we find out the exact number of people in the community and give them a code or machine gun number respectively. To select sample people from the table, we randomly start from a point of the table (by closing the eyes and placing a finger or the tip of the pen on the table) in the direction of the row or column. The chosen small number is actually the code of an individual from the community that is chosen as a sample. This work continues until a small number can be selected for the number of sample people. After the sample volume is complete, the sampling work ends.
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 Isfahan University of Medical Sciences
Street address
Hezar jarib Street. Azadai Square, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8173963181
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.ARI.MUI.REC.1401.338
Health conditions studied
1
Description of health condition studied
Bed Sore
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Frequency distribution of improvement rate in patients treated with collagen superabsorbent powder and silver sulfadiazine ointment
Timepoint
Measurement of the wound surface at the beginning of the study (before the start of the intervention) and every 48 hours after starting the use of collagen superabsorbent powder and silver sulfadiazine ointment.
Method of measurement
Using caliper software with a unit of mm
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After washing the wound with 0.9% sterile saline, the wound is placed in the open air for 5 minutes so that its surface is completely dry, then a few puffs of Nivasha nano silver spray (with a concentration of 15 ppm and health code 9655068437941620, manufactured by Nano Alvand Arad Company) is applied on the surface of the wounds to sterilize the surface of the wounds. After that, collagen superabsorbent powder containing silver nanoparticles (with a concentration of 15 ppm, manufactured by Nano Alvand Arad company) is poured on the wounds and a layer of Vaseline and sterile gauze is placed on the wounds and bandaged. The wound dressing is changed every 48 hours until the wound heals completely.
Category
Treatment - Drugs
2
Description
Control group: After washing the wound with 0.9% sterile saline, the wound is placed in the open air for 5 minutes so that its surface is completely dry, then a few puffs of Nivasha nano silver spray (with a concentration of 15 ppm and health code 9655068437941620, manufactured by Nano Alvand Arad Company) is applied on the surface of the wounds to sterilize the surface of the wounds. After that, 1% silver sulfadiazine ointment (with the trade name Flamexin, manufactured by Emad Darman Pars Pharmaceutical Company) is used, and a layer of Vaseline and sterile gauze is placed on the wounds and bandaged. Wound dressings are changed daily until the wound heals completely.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Wound healing clinics and nursing homes in Isfahan city
Full name of responsible person
Dr. Morteza Sanaguizade Isfahani
Street address
The first treatment clinic.Jey Street.Isfahan..
City
Isfahan
Province
Isfehan
Postal code
8173963183
Phone
+98 31 3230 0286
Email
drsanagoo52@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Building No. 4, Research and Technology Vice-Chancellor, Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?