Performing partial thickness skin graft from a flap of skin to repair defects resulting from the same flap in leg in patients with complex ulcers: a clinical trial
Objectives: To determine performance of partial thickness skin graft from a flap of skin to repair defects resulting from the same flap in leg in patients with complex ulcers
Design: a clinical trial.
Setting and conduct: The eligible patients with complex ulcers who are candidate for skin graft and will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: complex ulcers with indication of skin graft.
Exclusion criteria: inability to prepare skin graft.
Intervention group: Providing a thickness of 3 mm from the flap of skin graft to repair the defect resulting from the same flap of skin in legs.
Control group: without control group.
Primary outcome: Graft success on the fifth day after surgery through clinical examination.
Secondary outcome: (a) the patient satisfaction on the fifth day after surgery using standard questionnaire; (b) the severity of pain on the fifth day and the second week after surgery using a visual analog scale.
Randomization: This study has an intervention group without control group, therefore it is without randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611069014N132
Registration date:2016-11-09, 1395/08/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-09, 1395/08/19
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-06-22, 1395/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Performing partial thickness skin graft from a flap of skin to repair defects resulting from the same flap in leg in patients with complex ulcers: a clinical trial
Public title
Performing partial thickness skin graft from a flap of skin to repair defects resulting from the same flap in leg in patients with complex ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: complex ulcers with indication of skin graft.
Exclusion criteria: inability to prepare skin graft.
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: This study has an intervention group without control group, therefore it is without randomization.
Blinding: Not possible.
Secondary Ids
1
Registry name
the patient satisfaction
Secondary trial Id
on the fifth day after surgery
Registration date
empty
2
Registry name
the severity of pain
Secondary trial Id
on the fifth day and the second week after surgery
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.UMSHA.REC.1394.154
Health conditions studied
1
Description of health condition studied
complex ulcers
ICD-10 code
L98.4
ICD-10 code description
Chronic ulcer of skin, not elsewhere classified
Primary outcomes
1
Description
Graft success
Timepoint
on the fifth day after surgery
Method of measurement
through clinical examination
Secondary outcomes
1
Description
the patient satisfaction
Timepoint
on the fifth day after surgery
Method of measurement
using standard questionnaire
2
Description
the severity of pain
Timepoint
on the fifth day and the second week after surgery
Method of measurement
using a visual analog scale
Intervention groups
1
Description
Intervention group: Providing a thickness of 3 mm from the flap of skin graft to repair the defect resulting from the same flap of skin in legs.
Category
Treatment - Surgery
2
Description
Control group: without control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Yadollah Raeisi Makiani
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Yadollah Raeisi Makiani
Position
Resident of Surgery
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
dr.raissi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Mahdi Eskandarloo
Position
Surgeon
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
dr.escandarlou@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+81 38380090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)