Assessment of the efficacy of amnion dressing in wound healing of skin graft donor sites (superficial second-degree wound) in the lateral thigh and its comparison with conventional wound dressing
Determining and comparing the effect of amnion dressing on healing superficial second-degree burns wounds
Design
Two arms parallel-group randomized trial with a control group and blinded participants and phase 2 on 58 patients. The blocking method was used for randomization.
Settings and conduct
This study is performed in the burn department of Imam Reza Hospital.
58 patients with deep second-degree burns (less than 20% of burns) who require skin grafts are randomly assigned into two groups based on clinical symptoms confirmed by an infectious disease specialist and a plastic and burn surgeon. Group A patients receive amnion dressing and then dry gauze and bandaging, and group B patients receive the usual treatment (a layer of fatty gauze, dry gauze, and then bandaging). Every 48 hours, the secondary dressing, which includes dry gauze and a bandage, is replaced, and the donor site is evaluated in terms of infection and the progress of wound healing. An infectious disease specialist and a plastic and burn surgeon perform monitor all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients between the ages of 15 and 55 are eligible to participate.
Have a severe burn of grade 2 or higher that requires a skin graft
Patients with burns that are less than or equal to 20%
Patient with deep second degree burns in upper and lower limbs and anterior trunk except for lateral thigh
Criteria for not including people in the study:
Patients under 15 years and over 55 years
Patients with more than 20% burns
Burns in the lateral thigh area
Intervention groups
The intervention group consisted of 29 patients who underwent amnion dressing in their lateral thighs.
Main outcome variables
Duration of complete wound healing in the two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210918052511N1
Registration date:2021-09-24, 1400/07/02
Registration timing:prospective
Last update:2021-09-24, 1400/07/02
Update count:0
Registration date
2021-09-24, 1400/07/02
Registrant information
Name
Omid Yazarlu
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2073
Email address
yazarlouom@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the efficacy of amnion dressing in wound healing of skin graft donor sites (superficial second-degree wound) in the lateral thigh and its comparison with conventional wound dressing
Public title
Assessment of the efficacy of amnion dressing in wound healing of skin graft donor sites
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between the ages of 15 and 55 are eligible to participate.
Have a severe burn of grade 2 or higher that requires a skin graft
Patients with burns that are less than or equal to 20%
Patient with deep second degree burns in upper and lower limbs and anterior trunk except lateral thigh
Exclusion criteria:
Patients who are receiving chemotherapy
Patients taking corticosteroids or cytotoxic medicines
Pregnancy
Cancer, cytotoxic drugs, immunosuppressants, and the presence of chronic diseases other than diabetes that affect wound healing, such as severe vascular disease, lupus, rheumatoid arthritis, and renal failure
Smoking
The presence of an underlying disease leads to a defective immune system
Diabetic patients
Taking drugs that lead to a defective immune system.
Burns in the lateral thigh area.
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Each of the 58 patients would be assigned a number between 1 and 58 which is randomized by using random.org/integers in two columns. The numbers of the first column are assigned to group A and the second column is assigned to group B. With a lottery method, each column (A or B) is assigned to intervention or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Prior to participating in the trial, all patients or their legal representatives sign an informed consent form and are informed that they will be in one of two treatment groups. After that, participants enter the operating room and receive the dressing based on how the allocation occurred, and they are unaware of the type of dressing received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics committee of school of medicine-Mashhad university of medical sciences
Street address
Azadi squer- campus of Medical University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91379-13316
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.331
Health conditions studied
1
Description of health condition studied
Burn patients
ICD-10 code
T20
ICD-10 code description
Burn and corrosion of head, face, and neck
Primary outcomes
1
Description
Duration of complete wound healing
Timepoint
Every 48 hours
Method of measurement
Based on the clinical observations of an infectious disease specialist and plastic and burn surgeon
Secondary outcomes
1
Description
Wound condition, including the presence or absence (yes/no) of granulation tissue, bleeding, pain, infection, and other wound complications or healing factors are evaluated.
Timepoint
Every 48 hours
Method of measurement
Based on the scores of the variables and presence or absence (yes / no)
Intervention groups
1
Description
Intervention group: The amnion dressing is used for two weeks and this dressing is provided by Sinacell Co.Amnion membrane as a biological dressing in the treatment of burn wounds accelerates wound healing, reduces the need to change dressings, shorten the duration of hospitalization, reduce scar formation, temperature control, proper air permeability to the wound and reduce pain and earlier removal of the dressing . It is used once for dressing the donor site in the operating room and the secondary dressing (dry gauze and bandage) is changed every 48 hours.
Category
Treatment - Devices
2
Description
Control group: includes the conventional treatment (a layer of fatty gauze, dry gauze and then bandaging) for two weeks.