Evaluating the effect of amniotic membrane allograft on the duration of treatment of pilonidal sinus patients compared to conventional dressing methods
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 30 patients. The table of random numbers from www.randomization.com was used for randomization.
Settings and conduct
This study will be conducted in the surgery department of Qaem Hospital in Mashhad. 30 patients with pilonidal sinus are selected based on specific inclusion criteria and randomly divided into two intervention and control groups. The surgical procedure will be the same in both groups. In the control group, patients are subjected to routine care for secondary wound healing after surgery. In the intervention group, one week after surgery, patients undergo amniotic membrane transplantation and monitoring. At the end of the study, the two groups will be compared in terms of the duration of wound healing until the complete formation of the epithelium. The allocator of the sample to the groups and the data analyzer will be unaware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years old with the first episode of Pilonidal sinus disease one week after surgery, having Surgical wounds with a size of 4 x 4 cm and larger without infection.
Absence of sinus abscess and absence of underlying chronic diseases that impair wound healing, such as diabetes and connective tissue diseases, and not using glucocorticoid during the study period.
Intervention groups
In the intervention group, a skin patch of amnion membrane ill be placed on the wound one week after surgery. In the control group, the usual dressing methods are used.
Main outcome variables
The time required for wound healing until the complete formation of epithelium without evidence of separation of wound edges and necrosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221008056113N1
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
Mohammad Etezadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3514 5328
Email address
etezadpourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-05-14, 1403/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of amniotic membrane allograft with conventional dressing methods on the duration of treatment of pilonidal sinus patients
Public title
Evaluation of the effect of amniotic membrane allograft on duration and costs of treatment in pilonidal disease compared with conventional methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old with the first manifestation of pilonidal sinus disease one week after surgery
Surgical wounds with a size of 4 x 4 cm and larger without infection
Exclusion criteria:
Pilonidal sinus with abscess formation
Underlying chronic diseases that disrupt wound healing, such as diabetes and connective tissue diseases.
Glucocorticoid consumption during the study period
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method was used, in which the patients were divided into 6 blocks, and then the list of blocks was written and numbers were assigned to them. Then a random number between 1 and 5 is selected and finally the treatment allocation list is determined based on the previous random numbers. The randomization unit is individual, and the randomization tool is a table of random numbers. The random sequence was created using the table of random numbers through www.randomization.com. The method of concealment is the allocation of sealed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person allocating the sample to the groups and the person analyzing the data do not know the type of intervention.
Regarding the type of intervention, the participants and the medical personnel taking care of them as well as the main researcher (surgeon) are aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qaem hospital, Ahmad abad Ave, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699311
Approval date
2022-04-12, 1401/01/23
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.088
Health conditions studied
1
Description of health condition studied
Pilonidal sinus
ICD-10 code
L05.9
ICD-10 code description
Pilonidal cyst and sinus without abscess
Primary outcomes
1
Description
The time required for wound healing until the complete formation of the epithelium
Timepoint
After the initial visit one week after surgery, patients are examined two weeks later (i.e. the third week after surgery) and then weekly for 6 to 8 weeks (depending on the time required for wound healing).
Method of measurement
Examination of wounds is performed by a single experienced nurse and familiar with the wound healing process who will receive the necessary training.
Secondary outcomes
1
Description
Total cost for wound care, including the cost of purchasing dressings, antibiotics, and painkillers, as well as the cost of weekly visits.
Timepoint
At the end of the study
Method of measurement
All these costs are calculated regardless of insurance, and the patients will be asked at each visit and compared in two groups at the end of the complete recovery process.
Intervention groups
1
Description
Intervention group, in addition to the usual care of the wound, amnion-chorion dry sheets are used for dressing, and this product is provided under the brand name Life Cell from Bazar Teb Company. For this study, batch C4C6C7 of this
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem hopital
Full name of responsible person
zahra kargar
Street address
Ahmad abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699311
Phone
+98 51 3840 9642
Email
zahrakargar777@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Etezadpour
Street address
Ghaem Hospital, Ahmad Abad Ave, Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699311
Phone
+98 51 3840 9642
Email
etezadpourm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Asa Yousefi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
Ghaem Hospital, Ahmad Abad Ave, Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699311
Phone
+98 51 3840 9642
Email
yousefia952@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Asa Yousefi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
Ghaem Hospital, Ahmad Abad Ave, Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699311
Phone
+98 51 3840 9642
Email
Yousefia952@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Asa Yousefi
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
Ghaem Hospital, Ahmad Abad Ave, Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699311
Phone
+98 51 3840 9642
Email
Yousefia952@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After the completion of the study, the data related to the duration of wound healing in the study and control groups will be shared. A picture of the stages of wound healing in the intervention group will be taken at each visit and will be shared after making the people unidentifiable.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
access to these data will be allowed for surgeons and researchers in the field of wound healing, especially researchers who intend to conduct research on the effect of using amniotic membrane in other types of surgical wounds.
From where data/document is obtainable
The results of this research will be published on the website rpis.research.ac.ir.
These results can also be achieved by calling one of the researchers of this project named Zahra Kargar and submitting a request.
What processes are involved for a request to access data/document
The data can be obtained by registering in the rpis.research.ac.ir system and searching for the title of this research.
You can also get these data by sending a massage to the number 00989215569742 and submitting your research project proposal.