Determining the effect of dressing with amniotic membrane and usual dressing on healing rate and wound pain in patients with second degree pressure ulcer.
Design
Clinical trial with control group, double blind, randomized, on 58 patients. A coin toss will be used for randomization.
Settings and conduct
The location of the study is the internal and ICU departments of the Vali-e-Asr hospital in Arak 2- The study population: All patients with second-degree pressure ulcers 3- The study will be conducted double blind and the assessor and the patient will not be aware about the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
having grade 2 pressure ulcers;
having desire to participate in research;
Being able to answer questions.
Non-inclusion criteria:
contamination of patient's wound with contaminating substances; using a substance other than drinking water on the wound; Having symptomatic infection in different parts of the body
Intervention groups
Intervention group: amniotic dressing,
After washing the wound with normal saline, a layer of amniotic membrane is placed on the wound and covered with two or three layers of sterile gauze and bandaged with a sterile bandage.
Control group: Dressing with normal saline,
After washing the wound with normal saline, the wound is covered with two or three layers of sterile gauze and bandaged with a sterile bandage.
Main outcome variables
Healing rate, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180715040478N3
Registration date:2023-01-31, 1401/11/11
Registration timing:registered_while_recruiting
Last update:2023-01-31, 1401/11/11
Update count:0
Registration date
2023-01-31, 1401/11/11
Registrant information
Name
Azam Malekhoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
Azam.malekhoseini@khomeinums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-27, 1401/05/05
Expected recruitment end date
2023-07-27, 1402/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of amnion and normal saline on healingand wound pain in patients with second-degree pressure ulcers
Public title
The effect of amnion on the healing and second degree pressure ulcer pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants have grade 2 pressure ulcer
Willingness to participate in research
Be able to answer questions
Exclusion criteria:
The patient's wound is contaminated with contaminating substances.
Have used a substance other than drinking water on the wound
Have symptomatic infection in different parts of the body
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were selected from the study population by Convenience Sampling method and then by Simple Random allocation method (coin toss) ten people were placed in each group, after that the background characteristics of the patients were evaluated in each group. The next patient who entered the study was entered into a group that minimized the overall difference between the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted in a double-blind manner, and the evaluator and the patient will not know about the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Khomein University of Medical Sciences
Street address
Azadi Street
City
Khomein
Province
Markazi
Postal code
38818-58573
Approval date
2022-08-24, 1401/06/02
Ethics committee reference number
IR.KHOMEIN.REC.1401.007
Health conditions studied
1
Description of health condition studied
Bed sore
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
size of wound
Timepoint
The first, seventh and fourteenth days
Method of measurement
Using tape measure
2
Description
The amount of pain
Timepoint
The first, seventh and fourteenth days
Method of measurement
Visual Analogue Scale of Pain
Secondary outcomes
empty
Intervention groups
1
Description
The experimental group will be treated with amniotic membrane. In this way, after washing the wound with normal saline, a layer of amniotic membrane is placed on the wound and covered with two or three layers of sterile gauze and bandaged with a sterile bandage.
Category
Treatment - Drugs
2
Description
Control group: They will be treated with normal saline, so the wound is covered with two or three layers of sterile gauze and bandaged with a sterile bandage daily after washing the wound with normal saline.