comparison of the effectiveness of dry human amniotic membrane in secondary intention healing of full thickness and non-infected wounds of abdomen and genitalia following surgery or trauma in ICU patients
Evaluation of wound healing by using dry human amniotic membrane
Design
In this single-blind randomized clinical trial, patients with genitalia and abdominal open wounds who are candidate for secondary intention wound healing, were randomly assigned to two groups (at least 20) via sealed envelops and in one group first post operative dressing were done with dry human amniotic membrane and the other days wounds were dressed routinely and in the other group the wounds were dressed routinely without using amniotic membrane till patients discharged
Settings and conduct
All patients in Shohada Tajrish hospital and Imam Reza hospital with genitalia and abdominal open wounds who are candidate for secondary intention wound healing enrolled in this one side blind(patients) study, through sealed envelope patients were randomized to two groups and the effect of dry human amniotic membrane and routine wound dressing without amniotic membrane on wound healing of patients was compared
Participants/Inclusion and exclusion criteria
The patients >30 years old that have abdominal or genitalia open wound and candidate for secondary intention wound healing include in study and patients with infected wound or whom do not complete consent form exclude from study
Intervention groups
In one group the first dressing of wound was done with dry human amniotic membrane and for the next times till hospital discharge dressing was done routinely and in the other group wound was dressed routinely without amniotic membrane
Main outcome variables
situation of open wound healing
time to heal open wound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180218038788N2
Registration date:2020-06-16, 1399/03/27
Registration timing:registered_while_recruiting
Last update:2020-06-16, 1399/03/27
Update count:0
Registration date
2020-06-16, 1399/03/27
Registrant information
Name
amirhossein rahavian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
amirrahavian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effectiveness of dry human amniotic membrane in secondary intention healing of full thickness and non-infected wounds of abdomen and genitalia following surgery or trauma in ICU patients
Public title
effect of dry human amniotic membrane in wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age more than 30 y/o
Any underlying problem that may interfere with the tissue repair process including Diabetes. Immune deficiency diseases. Connective tissue disorders. heavy smoking or any other lung or heart disease that disrupts the oxygen supply to the tissue
Full thickness open wounds in the genital area and Perineum that due to inflammation, wound contamination or huge defect are not suitable candidates for primary healing
Aforementioned wounds that were repaired once and again for various reasons including hematoma, High tension on the repair site, Inappropriate blood supply and ... has been restored and cannot be repaired in the second time
Aforementioned wounds that are candidate for secondary intention based of physician opinion
Exclusion criteria:
active wound infection
lack of consent form completion by patient
patient death during study
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done from a computer-generated sequence(SAS software), concealed in sequentially numbered, sealed, opaque envelopes, and kept by the ward secretary
Blinding (investigator's opinion)
Single blinded
Blinding description
after explanation of study, all the participants are blind because patients divided to two groups by sealed envelops and same intervention was done for both groups but with different material.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
Tehran, West Fatemi Ave., Shahid Etemadzade Ave., AJA University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2020-05-26, 1399/03/06
Ethics committee reference number
IR.AJAUMS.REC.1399.053
Health conditions studied
1
Description of health condition studied
wound
ICD-10 code
S31
ICD-10 code description
Open wound of abdomen, lower back, pelvis and external genitals
Primary outcomes
1
Description
wound healing time
Timepoint
14-30-90 days
Method of measurement
physical examination by physician
Secondary outcomes
1
Description
wound infection rate
Timepoint
14-30-90 days
Method of measurement
wound culture
2
Description
hospital admission time
Timepoint
14-30-90 days
Method of measurement
admission and discharge date
Intervention groups
1
Description
Intervention group: On the first or second day after surgery or trauma, if the wound is not infectious, a dry human amniotic membranes are placed on the wound and dressing is performed.
Category
Treatment - Other
2
Description
Control group: On the first or second day after surgery or trauma, if the wound is not infectious, the dressing is done routinely without an amniotic membrane.