Protocol summary

Study aim
Comparison of repair with Eloderm and individual skin graft in terms of recovery time, cost, contouring and sensation
Design
Phase two on two groups of 25 people will be randomly randomized, one will be repaired with autograft and the other will be repaired with allograft. The study is one-sided blind and only the patients do not know about the type of surgery and treatment selected. Also, this study will be conducted with parallel groups.
Settings and conduct
Performing reconstructive surgery for hand injuries in patients referred to Hazrat Fatemeh Hospital. The selection of the type of repair is explained based on the random selection and will be based on a lottery, in one group the repair will be done with allograft from cadaver and in the other group, the repair will be done with the person's own full-thickness autograft. In this study, only the participants did not know about the type of surgery, and the researcher and evaluator of the information were aware of the type of surgery, so the study is single-blind
Participants/Inclusion and exclusion criteria
Inclusion criteria: Complete skin damage of fingers and hand at volar or palmar level, People between 18 and 60 years old Exclusion criteria: People with a history of connective tissue disease and vascular collagen, People with a history of Steroid use, Smokers, Wounds with bone surfaces and open tendons
Intervention groups
In one group, repair is done with hypotenar full thickness autograft, and in the intervention group, repair is done using Eloderm dressing along with split thickness autograft, which is a thin layer of epidermis
Main outcome variables
Evaluation of patients in terms of sensation, graft contouring, skin color, recovery time, treatment cost and duration of surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230219057450N1
Registration date: 2023-02-25, 1401/12/06
Registration timing: prospective

Last update: 2023-02-25, 1401/12/06
Update count: 0
Registration date
2023-02-25, 1401/12/06
Registrant information
Name
Mohamad Mehran Aminifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 7272
Email address
aminimeehraan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-16, 1401/12/25
Expected recruitment end date
2023-08-16, 1402/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of repair of acute full-thickness defect wounds of the hand in repair with Alloderm compared to skin grafting
Public title
Comparison of repair of acute full-thickness defect wounds of the hand in repair with Alloderm compared to skin grafting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Complete skin damage of the fingers and hands at the volar or palmar level People between 18 and 60 years old
Exclusion criteria:
People with a history of connective tissue, collagen and scholar disease People with a history of steroid use Smokers Wounds with open bony and tendon surfaces
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we numbered 50 papers in a container that cannot be seen from the outside and assigned number 1 to 25 papers and number 2 to the other 25, then before each patient's surgery in the operating room, we took out a paper from the container. And based on number 1 (repair with Eloderm) or 2 (repair with patient's skin graft), we determine the type of operation
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is of a blind type, in which the patient is not aware of the study process and the placement of the study groups, but the researcher and evaluator of the information in the process of placement of people in the groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-02-15, 1401/11/26
Ethics committee reference number
IR.IUMS.FMD.REC.1401.656

Health conditions studied

1

Description of health condition studied
Patients with acute hand injuries
ICD-10 code
S69.8
ICD-10 code description
Other specified injuries of wrist and hand

Primary outcomes

1

Description
Recovery time
Timepoint
Immediately after surgery to six months after surgery
Method of measurement
Based on calendar days

Secondary outcomes

1

Description
Skin contouring
Timepoint
Three months and six months after surgery
Method of measurement
Based on qualitative skills

2

Description
Having sense
Timepoint
Three months and six months after surgery
Method of measurement
Direct assessment by pressure on the repair site

Intervention groups

1

Description
Intervention group: Treatment with Aloderm Split Graft
Category
Treatment - Surgery

2

Description
Control group: Treatment with one's own full-thickness autograft
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrate Fatemeh Hospital
Full name of responsible person
Mohamad Mehran Aminifard
Street address
Seyed Jamalodin Asadabadi St.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
aminimeehraan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
حسین کیوانی
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hazrate Fatemeh Hospital
Proportion provided by this source
100
Public or private sector
Public
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
Iran University of Medical Sciences
Full name of responsible person
Mohamad Mehran Aminifard
Position
Specialist assistant
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Seyed Jamalodin Asadabadi st.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
Email
aminimeehraan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Yousef Shafaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic and Reconstructive Surgery
Street address
Seyed Jamalodin Asadabadi St.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
dr.yousefshafaei@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohamad Mehran Aminifard
Position
Specialist assistant
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Seyed Jamalodin Asadabadi st.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
Email
aminimeehraan@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data file of the participants and the study protocol will be provided to the people after the study is done in the article and the final report of the thesis. Also, the informed consent form can be downloaded in the appendix of the thesis
When the data will become available and for how long
One year after the end of the study
To whom data/document is available
All researchers who have a topic similar to the current research work
Under which criteria data/document could be used
For modeling and guidance
From where data/document is obtainable
Public official Mohammad Mehran Amini Fard aminimeehraan@gmail.com
What processes are involved for a request to access data/document
After sending an email to the public official and mentioning the title of your research work, a response will be given within 2 weeks at the discretion of the public official
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